PL-1808: Package Insert and Label Information

PL-1808- alcohol gel
PL-1807- alcohol gel
Broder Bros Co.,

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.

Ethyl Alcohol (62%)

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on skin

Warnings

Flammable. Keep away from heat and flame.

Warnings

For external use only.

Warnings

When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water.

PL-1807 back
(click image for full-size original)

Warnings

Stop use & ask a doctor if skin irritation develops and continues for more than 72 horus.

Warnings

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • Always supervise children in use of this product

Other Information

  • Do not store above 105 F (40.55 C)
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Other information

PL-1808 back label

Inactive ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Questions?

1-800-873-7746 M-F 8am-5pm EST

Lot no:

Use by:

Made in China

Distributed by: Prime Resource Corp Bridgeport, CT 06610

Hand Sanitizer

Hand Sanitizer

Net wt. 0.66 FL OZ (19.52 mL)

PL-1807 label -- front
(click image for full-size original)

Hand Sanitizer

2.19 oz. (64.76 mL)

PL-1808 front label
(click image for full-size original)

PL-1808
tee sanitizer spray . gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71513-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 62 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
CARBOMER 940
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71513-101-01 65 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/20/2017
PL-1807
tee sanitizer spray . gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71513-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 62 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
CARBOMER 940
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71513-100-01 20 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/20/2017
Labeler — Broder Bros Co., (005381652)
Registrant — Broder Bros Co., (005381652)
Establishment
Name Address ID/FEI Operations
Prime Resources Corp 099761066 relabel (71513-100), repack (71513-100), relabel (71513-101), repack (71513-101)
Establishment
Name Address ID/FEI Operations
Yuyao Jessie Commodity Co., Ltd. 529892305 manufacture (71513-100), manufacture (71513-101)

Revised: 09/2019 Broder Bros Co.,

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 © 2021. All Rights Reserved.