Hand Sanitizer by B & J Group Hand Sanitizer, Gel

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.

----------

Hand Sanitizer, Gel

Drug Facts

Active Ingredient(s)

Ispropyl alcohol 70% v/v

Purpose

Anitmicrobial

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 and excessive heat above 40C (104F)

Inactive Ingredients

glycerin, carbomer, water, fragrance

Package Labeling:

Label

HAND SANITIZER
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69737-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69737-001-00	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/15/2020	12/05/2022

Labeler - B & J Group (064604222)

Revised: 12/2021

Document Id: d3217ff7-789f-44d0-e053-2995a90ace10

Set id: 004d26c6-90eb-4f8c-a763-30572a9fb70d

Version: 3

Effective Time: 20211214

Trademark Results [Hand Sanitizer]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10