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 IngredientPurpose
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

Antibacterial_1 gallon

CHARM-TEX ANTIBACTERIAL 
benzethonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-3100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40057-3100-13785 mL in 1 BOTTLE; Type 0: Not a Combination Product02/02/202212/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/02/202212/31/2022
Labeler - Charm-Tex, Inc. (058347543)

Revised: 1/2023
Document Id: 0644c8fb-837a-0c43-e063-6294a90afa52
Set id: d6ea0f56-28cf-c9e8-e053-2a95a90aa785
Version: 2
Effective Time: 20230101
 
Charm-Tex, Inc.