Genuine First Aid – Auto First Aid: Package Insert and Label Information

GENUINE FIRST AID — AUTO FIRST AID — benzalkonium chloride, ibuprofen, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen
Genuine First Aid, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient: Purpose
Isopropyl Alcohol, 70% v/v…………… Antiseptic

Use: For preparation of skin before injection.

Warnings: For external use only.

Flammable — keep away from fire or flame
Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Do not use: with electrocautery, in the eyes.

Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Keep out of reach of children. If swallowed,
get medical help or contact a Poison Control
Center right away.

Wipe Injection site vigorously and discard.

Inactive Ingredient: Purified water.

LOT/EXP: Made in CHINA
20140301

Alcohol Cleansing Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID

Active Ingredient: ………Bacitracin Zinc 400 units

Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

Polymyxin B Sulfate 5000 units

Uses: To help prevent infection in:
minor cuts; scrapes; burns

Warnings:

For external use only.

Do not use: in eyes; over large areas of the body;

If allergic to any of the ingredients; for more than one week unless directed by a physician.

Stop use and consult a doctor:

if the condition persists or gets worse; a rash or other allergic reaction develops

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

Other information:

Store at room temperature.

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.

Active ingredient (in each tablet) Purpose

Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug


Uses temporarily relieves minor aches and pains due to:
the common cold
headache
toothache
muscular aches
backache
minor pain of arthritis
menstrual cramps temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach
bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.
Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Ask a doctor before use if you are:
taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug
When using this product:
take with food or milk if stomach upset occurs
Stop use and ask a doctor If:
you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.
Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.

Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

IBUPROFEN 2 Tablets

IBUPROFEN 2 Tablets

Active Ingredient (in each tablet) Purpose

Acetaminophen 500 mg…………………………. Pain Reliever / fever reducer

Purpose: Pain reliever, fever reducer

Uses for the temporary relief of minor aches and pains associated with
headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

Warnings

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.

Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swellign is present

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

If pregnant or breast-feeding, ask a health professional before use.

Adults and children: (12 years and older)
take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:
do not give to children under 12 years of age.

Store at 59 — 86 degree Fahrenheit (15 — 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

Active Ingredient: Purpose

Benzalkonium Chloride 0.40%………. First Aid Antiseptic

Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warning: For external use only.

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Do not use in the eyes or over large areas of the body.

Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive Ingredient: Purified water

LOT/EXP: Made in CHINA

20130301

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

AntisepticTowelette
(click image for full-size original)

GenuineTripleAntibiotic
(click image for full-size original)

Ibuprofen 200mg
(click image for full-size original)

AlcoholCleansingPad
(click image for full-size original)

APAP_PDP
(click image for full-size original)
apap_pdp
(click image for full-size original)
AUTO KIT FRONT
(click image for full-size original)
AUTO KIT BACK
(click image for full-size original)
GENUINE FIRST AID — AUTO FIRST AID benzalkonium chloride, ibuprofen, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-1000
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-1000-1 1 KIT (KIT) in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 0.5 g
Part 2 1 PACKET 2
Part 3 1 PACKET 2
Part 4 2 PACKAGE 1.6 mL
Part 5 2 PACKAGE 1 mL
Part 1 of 5
GENUINE TRIPLE ANTIBIOTIC bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
Product Information
Item Code (Source) NDC:52124-0003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 400 [iU] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0003-1 .5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/11/2011
Part 2 of 5
IBUPROFEN ibuprofen tablet
Product Information
Item Code (Source) NDC:52124-0009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
POWDERED CELLULOSE
STARCH, CORN
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
POVIDONE
SILICON DIOXIDE
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;352
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0009-1 2 TABLET (TABLET) in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075010 01/11/2011
Part 3 of 5
MEDIQUE APAP EXTRA STRENGTH acetaminophen tablet, film coated
Product Information
Item Code (Source) NDC:47682-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOL
POVIDONE
PROPYLENE GLYCOL
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code AZ;235
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47682-175-46 2 TABLET, FILM COATED (TABLET) in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/11/2011
Part 4 of 5
ANTISEPTIC TOWELETTE benzalkonium chloride swab
Product Information
Item Code (Source) NDC:52124-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.40 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333E 01/11/2011
Part 5 of 5
ALCOHOL CLEANSING PAD isopropyl alcohol liquid
Product Information
Item Code (Source) NDC:52124-0002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0002-1 0.5 mL in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/11/2011
Labeler — Genuine First Aid, LLC (619609857)

Revised: 01/2011 Genuine First Aid, LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.