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

Triclocarban 1.50%

Purpose

Antibacterial

Uses

For hand washing 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 hours 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

Package Labeling:

label

AMERFRESH ANTIBACTERIAL DEODORANT
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51460-3000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PEG-6 METHYL ETHER (UNII: WXH089JZ5E)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SORBITOL (UNII: 506T60A25R)
EDETATE SODIUM (UNII: MP1J8420LU)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51460-3000-1	1 in 1 BOX	11/11/2015	08/31/2017
1		84.5 g in 1 PACKAGE; 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	11/11/2015	08/31/2017

Labeler - Amercare Products, Inc. (879289254)

Revised: 10/2017

Document Id: 5c53ed36-b807-10b9-e053-2a91aa0a597d

Set id: cf08cb0e-dcac-488d-b277-3afc04e178c8

Version: 3

Effective Time: 20171024

Amercare Products, Inc.