ACURE HAND SANITIZER- alcohol gel
Better Planet Brands 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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ACURE Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

If irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

Put enough product in your palm to cover hands and rub hands together until dry.
Children under 6 years of age should be supervised when using this product.

Other information

Store below 110˚F (43˚C). May discolor certain fabric surfaces.

Inactive ingredients

WATER/AQUA, GLYCERIN, ALOE BARBADENSIS LEAF JUICE, CARBOMER, AMIDOMETHYL PROPANOL.

Questions?

Call toll-free 877.902.2873

Package Labeling:

Label

ACURE HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54136-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54136-007-05	147 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/15/2020	12/31/2022

Labeler - Better Planet Brands LLC (960253719)

Revised: 10/2022

Document Id: eb4e8327-35ab-b45b-e053-2995a90aaecd

Set id: a6a348fd-b50a-2280-e053-2a95a90a4c6f

Version: 2

Effective Time: 20221018

Better Planet Brands LLC