Charm-Tex Antibacterial Soap (DEACTIVTED)

Charm-Tex Antibacterial by

Drug Labeling and Warnings

Charm-Tex Antibacterial by is a Otc medication manufactured, distributed, or labeled by Charm-Tex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHARM-TEX ANTIBACTERIAL- benzethonium chloride soap 
Charm-Tex, 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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Charm-Tex Antibacterial Soap (DEACTIVTED)

Drug Facts

Active Ingredient & Purpose

Antiseptic

• Active Ingredient: Purpose
• Benzethonium choloride 0.1%..............................: Antibacterial

Uses

For hand washing to

• decreases bateria on the skin
• reduce chance f cross-infection

Warnings

For external use only. Avoid contact with eyes.

Do not use

on infants under 6 months of age.

Stop use and ask a doctor if

irritation or redness develops.

Keep out of reach of children.

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

Directions

• wet skin
• spread a small amount of soap on hands and forearms
• scrub well for at least 15 seconds
• rinse thoroughly after washing and dry

Other information

• do not use if seal under cap is torn, broken or missing.

Inactive ingredients

cocamidopropyl betaine, coco diethanolamine, edetale disodium anhydrous, FD&C red no. 4 (CI 14700), FD&C yellow no. 5 (CI19140), fragrance, peg-7 glyceryl cocoate, phenoxyethanol, propylene glycol, sodium chloride, sodium lauryl sulphate, water.

Questions & comments?

1-800-221-3147 (M-F) 9 AM to 5 PM EST or www.charm-tex.com

Exclusive Distributor:

Charm-Tex, Inc.
1618 Coney Island Ave
Brooklyn NY 11230 USA

Made in India
E.C.No: GUJ/COS/GC/1348

Package Label - Principal Display Panel

1 Gallon (128 oz) 3785 ml

NDC: 40057-3100-1

CHARM-TEX ANTIBACTERIAL 
benzethonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40057-3100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40057-3100-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2022	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/02/2022	12/31/2022

Labeler - Charm-Tex, Inc. (058347543)

Revised: 1/2023

Document Id: 0644c8fb-837a-0c43-e063-6294a90afa52

34390-5

Set id: d6ea0f56-28cf-c9e8-e053-2a95a90aa785

Version: 2

Effective Time: 20230101