ATHLETICARE ANTI-BACTERIAL HAND AC 550- triclosan 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 Anti-Bacterial Hand Soap AC 550

Drug Facts

Active Ingredient

Triclosan 0.25%

Purpose

Antibacterial

Uses

- For hand washing to decrease bacteria on the skin.

Warnings

For External Use only

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water. Discontinue use and consult a health practitioner if irritations develop.

Keep out of reach of children.

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

Directions

Pump product into hands, lather vigorously for 15 seconds, rinse. Use as part of your daily cleansing routine.

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Propylene Glycol, Disodium EDTA, Hydroexyethyl Cellulose, Guar Hydroxypropyltrimonium Chloride, Methylchloroisothiazolinone, Allantoin, Fragrance, Red 4.

Package Labeling:

Label2 Label3

ATHLETICARE ANTI-BACTERIAL HAND AC 550
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42326-550
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ALLANTOIN (UNII: 344S277G0Z)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42326-550-01	1 in 1 CARTON	03/05/2016	05/23/2021
1		4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/05/2016	05/23/2021

Labeler - Petra Hygienic Systems Int Ltd (248228199)

Revised: 1/2020

Document Id: 97b8c8d4-d8c1-5146-e053-2a95a90a340c

Set id: 4d8fdaa7-a6ec-4cf3-9cf0-34931fbee2e2

Version: 4

Effective Time: 20200124

Petra Hygienic Systems Int Ltd