ATHLETICARE NO-RINSE HAND SANITIZING AC 575- ethyl alcohol gel 
Petra Hygienic Systems Int Ltd

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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Athleticare No-Rinse Hand Sanitizing Gel AC 575

Drug Facts

Active Ingredient

Ethyl Alcohol 70 % v/v

Purpose

Antibacterial

Uses

- For hand sanitizing to decrease bacteria on the skin

Warnings

- For External Use only. Flammable.

When using this product

avoid contact with eyes and keep away from sources of heat. In case of eye contact, flush eyes with water.

Stop use and consult

a doctor if irritations occur.

Keep out of reach of children.

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

Directions

Place enough product in your palm to thoroughly cover your hands - Rub hand together briskly until dry - Children ages 6 and under should be supervised when using this product.

Inactive Ingredients

Water, Triethanolamine, Acrylates / C10-30 Alkyl Acrylate Cross-Polymer, Fragrance, Aloe Vera Gel

Package Labeling:

Label5Label3

ATHLETICARE NO-RINSE HAND SANITIZING AC 575 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42326-575
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42326-575-011 in 1 CARTON03/05/201606/18/2020
14000 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/05/201606/18/2020
Labeler - Petra Hygienic Systems Int Ltd (248228199)
Establishment
NameAddressID/FEIBusiness Operations
Petra Hygienic Systems Int Ltd248228199manufacture(42326-575)

Revised: 12/2020
Document Id: b7c5667c-ba22-76d5-e053-2a95a90a1c35
Set id: b20081de-e6ae-4ee8-af8a-d33b08b27aef
Version: 6
Effective Time: 20201231
 
Petra Hygienic Systems Int Ltd