AMERFRESH ANTIBACTERIAL DEODORANT- triclocarban soap
Amercare Products, Inc.

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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AMERFRESH ANTIBACTERIAL DEODORANT SOAP

DRUG FACTS

Active Ingredient Purpose

Triclocarban 1.50% Antibacterial

Purpose Antibacterial

Uses

For Handwashing to decrease bacteria on the skin

Warnings

For External Use Only

Do not use in the eyes. If contact occurs, flush eyes with water.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hour consult a doctor.

Keep out of reach of children

If swallowed get medical help or contact poison control center right away.

Directions

Lather on wet skin and rinse well.

Inactive Ingredients

Fragrance, glycerin, PEG-6 Methyl Ether, Pentasodium Pentetate, Sodium Chloride, Sodium Cocoate and/or Sodium Palm Kernelate, Sodium Tallowate, Sorbitol, Tetrasodium EDTA, Tetrasodium Etidronate, Water.

Distributed by:

Amercare Products, Inc.

17661 128th Place NE

Woodinville, WA 98072-8783

PRODUCT OF CHINA

AMERFRESH

ANTIBACTERIAL DEODORANT SOAP

Net Wt. 1.5 oz (42.5g)

amerfreshsoap

AMERFRESH ANTIBACTERIAL DEODORANT
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51460-0275
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
DIMETHYL ETHER (UNII: AM13FS69BX)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51460-0275-1	42.5 g in 1 PACKAGE; Type 0: Not a Combination Product	09/03/2010	05/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/03/2010	05/01/2020

Labeler - Amercare Products, Inc. (879289254)

Revised: 5/2018

Document Id: 6cc9e9fc-23f6-00fd-e053-2991aa0ab86a

Set id: 7fb742f1-50e0-4b7c-b924-0a07157ac9eb

Version: 3

Effective Time: 20180522

Amercare Products, Inc.