4238 First Aid Kit: Package Insert and Label Information

4238 FIRST AID KIT-
Honeywell Safety Products USA, INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

First Aid Burn Cream
Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%

First Aid Burn Cream
Purpose

First aid antiseptic

External analgesic

First Aid Burn Cream Uses

• prevent skin infection
• for temporary relief of pain associated with minor burns

First Aid Burn Cream

Warnings

For external use only

Do not use

• in or near the eyes
• if you are allergic to any of the ingredients
• in large areas of the body, particularly over raw surfaces or blistered areas
• for more than 10 days

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occurs again within a few days

First Aid Burn Cream

Directions

• adults and children 2 years of age and older:
• clean the affected area
• apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: consult a doctor

First Aid Burn Cream

Other information

• tamper evident sealed packets
• do not use if packet is opened or torn

First Aid Burn Cream

Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

First Aid Burn Cream Questions

1-800-430-5490

Alcohol Wipe Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe Purpose

First aid antiseptic

Alcohol Wipe Uses

• first aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe

Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burn

When using this product

• do not use longer than one week unless directed by a doctor

Stop use and consult a doctor

• if condition persists or gets worse

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Alcohol Wipe

Directions

• clean the affected area
• apply wipe to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard wipe after single use

Alcohol Wipe

Other information

store at room temperature 15 ⁰ to 25 ⁰ C (59 ⁰ to 77 ⁰ F)

Alcohol Wipe Inactive ingredient

water

Alcohol Wipe Questions

1-800-430-5490

Eyewash Active ingredient

Sterile Water 99%

Eyewash Purpose

Eyewash

Eyewash Uses

• for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyewash

Warnings

For external use only Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.

Do not use

• if solution changes color or becomes cloudy
• if you have open wounds in or near the eyes, get medical help right away.

Stop use and ask a doctor if

• you experience eye pain
• changes in vision
• continued redness or irritation of the eye
• condition worsens or persists

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Eyewash Directions

• remove contacts before using
• twist top to remove
• flush the affected area as needed
• control rate of flow by pressure on the bottle
• if necessary, continue flushing with emergency eyewash or shower

Eyewash

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyewash Questions

1-800-430-5490

PVP Active Ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

PVP Purpose

First aid antiseptic

PVP Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

PVP

Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body
• on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

• deep or puncture wounds,
• animal bites
• serious burns

When using this product

• do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

• conditions persists or gets worse
• irritation and redness develops

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away

PVP

Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

• clean affected area
• apply to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard swab after single use

PVP Other informatiion

• store at room temperature away from light
• keep from freezing or excessive heat
• do not use if package is torn or open

PVP

Inactive ingredient

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

PVP Questions

1-800-430-5490

Sting Relief Active ingredient (in each wipe)

Ethyl alcohol 50.0% Lidocaine HCl 2.0%

Sting Relief

Purpose

Antiseptic

Topical pain relief

Sting Relief
Uses

• prevent infection in minor scrapes, and temporary relief of itching of insect bites

Sting Relief
Warnings

For external use only Flammable, keep away from open fire or flame

Do not use

• over large areas of the body
• in eyes
• over raw or blistered areas

Stop use and ask a doctor

• if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Stig Relief

Directions

adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
children under 2 years of age: consult a doctor.

Sting Relief
Inactive ingredients

benzalkonium chloride, menthol, and purified water

Questions or Comments?

1-800-430-5490

4238 013087-1725A Kit Contents

1 KNUCKLE BAND 8 PER

1 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE PADS, 3″ X 3″, 4 PER

1 ADH TAPE, .5″ X 2.5 YD, 2 PER

1 GAUZE COMPRESS, 1728 SQ IN 1

1 INSTANT COLD PACK 4″ X 6″

1 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 4″ OFFSET, 1 PER

1 ADHESIVE BDG,PLSTIC,1″X3″16PER

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 MICROSHIELD W/VNL GLV/ALCL

LBL STOCK 6-3/8″X4″

LBL STOCK 4″X2-7/8″

1 LBL STOCK 3″x1-7/8″

1 KIT STL 16 UN (VERTICAL)

1 LABL INSTR FA REV A

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 STING Relief WIPES 10

First Aid Burn Cream Principal Display Panel

Alcohol Wipe Principal Display Panel

Eyewash Principal Display Panel

PVP Principal Display Panel

Sting Relief Principal Display Panel

4238 Kit Label 013087-1725A

4238 FIRST AID KIT 4238 first aid kit kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4238

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0498-4238-01 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 5.4 g Part 2 1 BOTTLE 30 mL Part 3 4 POUCH 1.6 mL Part 4 10 POUCH 3 mL Part 5 10 POUCH 4 mL

Part 1 of 5 FIRST AID BURN benzalkonium chloride, lidocaine hydrochloride cream

Product Information Item Code (Source) NDC:0498-0903 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL ALOE VERA LEAF WATER STEARIC ACID METHYLPARABEN CETYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE LIGHT MINERAL OIL EDETATE DISODIUM (EDETIC ACID) TROLAMINE GLYCERIN PROPYLPARABEN DIAZOLIDINYL UREA

Packaging # Item Code Package Description Multilevel Packaging 1 0.9 g in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/20/2017

Part 2 of 5 EYESALINE EMERGENCY EYEWASH purified water liquid

Product Information Item Code (Source) NDC:0498-0100 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (WATER) WATER 98.6 mL in 100 mL

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0498-0100-01 30 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018

Part 3 of 5 ALCOHOL WIPE isopropyl alcohol swab

Product Information Item Code (Source) NDC:0498-0143 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0498-0143-04 0.4 mL in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018

Part 4 of 5 PVP IODINE WIPE povidone-iodine 10% swab

Product Information Item Code (Source) NDC:0498-0121 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (IODINE) IODINE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0498-0121-00 0.3 mL in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/18/2018

Part 5 of 5 STING RELIEF PAD ethyl alcohol, lidocaine swab

Product Information Item Code (Source) NDC:0498-0733 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL ALCOHOL (ALCOHOL) ALCOHOL 0.5 mL in 1 mL

Inactive Ingredients Ingredient Name Strength MENTHOL WATER BENZALKONIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0498-0733-00 0.4 mL in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/14/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/14/2019

Labeler — Honeywell Safety Products USA, INC (079287321)

Establishment
Name	Address	ID/FEI	Operations
Honeywell Safety Products USA, INC		079287321	pack (0498-4238)

Establishment
Name	Address	ID/FEI	Operations
Water-Jel Technologies		155522589	manufacture (0498-0903)

Establishment
Name	Address	ID/FEI	Operations
Honeywell Safety Products USA, Inc.		167518617	manufacture (0498-0100)

Establishment
Name	Address	ID/FEI	Operations
Changzhou Maokang Medical		421317073	manufacture (0498-0143)

Establishment
Name	Address	ID/FEI	Operations
Sion Biotext Medical		532775194	manufacture (0498-0121)

Establishment
Name	Address	ID/FEI	Operations
Safetec of America Inc		874965262	manufacture (0498-0733)

Revised: 03/2019 Honeywell Safety Products USA, INC