Hand Sanitizer by B & J Group Hand Sanitizer, Gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by B & J Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- isopropyl alcohol gel 
B & J Group

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.

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Hand Sanitizer, Gel

Drug Facts

Active Ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antimicrobial

Use(s)

Hand sanitizer that can help reduce bacteria that can cause disease. Recommended for repeated use.

Warnings

Flammable. Keep away from heat or flame. For external use only.

Do not use

• In children less than two months of age
• On open skin wounds

When using this product

do NOT use near eyes, ears or mouth. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of the reach of children.

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

Direction

• Place enough product on hands to cover your hands. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

• Store between 15-30C (59-86F)
• Avoid freezing or heat above 40C (104F)

Inactive Ingredients

glycerin, carbomer, water, fragrance

Package Labeling:118.3ml

Package Labeling:236.6ml

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69737-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69737-003-00	118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	12/05/2022
2	NDC: 69737-003-01	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	12/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/06/2020	12/05/2022

Labeler - B & J Group (064604222)

Establishment
Name	Address	ID/FEI	Business Operations
B & J Group		064604222	manufacture(69737-003)

Revised: 12/2021

Document Id: d3d1a54b-5afc-fbc1-e053-2995a90a6237

34390-5

Set id: 243056d4-1ef8-4346-8920-38cd70a34652

Version: 3

Effective Time: 20211223