CHARM-TEX ANTIBACTERIAL- benzethonium chloride soap
Yangzhou Tracey Daily Chemical Plastic Co., 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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charm-tex Antibacterial soap

Drug Facts

Active Ingredient

Benzethonium Chloride 0.1%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on skin.

Warnings

For External Use Only.

Do not use this product on infants under 6.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask doctor if irritation and redness develops.

Keep out of reach of children.

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

Directions

Wet bar with water
Lather vigorously and wash skin
Rinse and dry thoroughly

Inactive Ingredients

Soap (Sodium Palmate and/or Sodiun Tallowate. Sodium Cocoate and/or Sodium Palm Kernelate) Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid,Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous.

CHARM-TEX ANTIBACTERIAL
benzethonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73343-001
Route of Administration	CUTANEOUS

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

Ingredient Name	Strength
Inactive Ingredients
SODIUM PALMATE (UNII: S0A6004K3Z)
COCONUT ACID (UNII: 40U37V505D)
PALM ACID (UNII: B6G0Y5Z616)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73343-001-01	1 in 1 CASE	09/10/2019
1		14 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:73343-001-02	1 in 1 CASE	09/10/2019
2		43 g in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC:73343-001-03	1 in 1 CASE	09/10/2019
3		85 g in 1 APPLICATOR; 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	09/10/2019

Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Tracey Daily Chemical Plastic Co Ltd		560398069	manufacture(73343-001)