ACURE Hand Sanitizer by Better Planet Brands LLC ACURE Hand Sanitizer Gel

ACURE Hand Sanitizer by

Drug Labeling and Warnings

ACURE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Better Planet Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 54136-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54136-007-05147 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/15/202012/31/2022
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