Hand Sanitizer by Batallure Beauty LLC Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Batallure Beauty LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Batallure Beauty 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.

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Hand Sanitizer

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Children under 6 years of age should be supervised when using this product to avoid swallowing.

Other information

Store between 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)
May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients

Water (Aqua), Aloe barbadensis leaf extract, Acrylates/C10-30 alkyl acrylate crosspolymer, Fragrance, Triethanolamine

Package Label - Principal Display Panel

236 mL NDC: 76786-074-03

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76786-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76786-074-03	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/18/2021	11/01/2022

Labeler - Batallure Beauty LLC (790417534)

Revised: 11/2021

Document Id: cfd4074d-4c96-f118-e053-2a95a90a35e6

34390-5

Set id: b8a2ff81-ed80-a311-e053-2995a90ab817

Version: 2

Effective Time: 20211102