Athleticare Alcohol-Free Foaming Hand Sanitizer AC 585-F

Athleticare Alcohol-Free Foaming Hand Sanitizer AC 585-F by

Drug Labeling and Warnings

Athleticare Alcohol-Free Foaming Hand Sanitizer AC 585-F by is a Otc medication manufactured, distributed, or labeled by Petra Hygienic Systems Int Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ATHLETICARE ALCOHOL-FREE FOAMING HAND SANITIZER AC 585-F- benzalkonium chloride liquid 
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 Alcohol-Free Foaming Hand Sanitizer AC 585-F

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

- For hand sanitizing to decrease bacteria on the skin

- Recommended for repeated use.

Warnings

For External Use only

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and consult a doctor

if irritations or redness develops or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Place a small amount of foam onto palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Centrimonium Chloride, Glycerin, Citric Acid, Polysorbate 20, Fragrance.

Package Labeling:

Drug FactsFront Label

ATHLETICARE ALCOHOL-FREE FOAMING HAND SANITIZER AC 585-F 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42326-586
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42326-586-014000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/202006/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/202006/18/2020
Labeler - Petra Hygienic Systems Int Ltd (248228199)
Establishment
NameAddressID/FEIBusiness Operations
Petra Hygienic Systems Int Ltd248228199manufacture(42326-586)

Revised: 12/2020
Document Id: b7c5667c-ba24-76d5-e053-2a95a90a1c35
Set id: a901df9d-b2af-5ec2-e053-2995a90a2415
Version: 2
Effective Time: 20201231