CharmTex Antibacterial Soap  406

CharmTex Antibacterial Soap  406

Drug Labeling and Warnings

Drug Details

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CHARMTEX ANTI BACTERIAL- parachlorometaxylenol liquid 
Inopak, 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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CharmTex Antibacterial Soap  406

Active Ingredient

Parachlorometaxylenol

Purpose

Antibacterial

Uses

Handwash to help reduce bacteria on the skin that

   potentially can cause disease.

Recommended for repeated use.

Warnings

Warnings

For external use only.

Keep out of eyes, ears, or mouth. In case of eye 

   contact, flush eyes with water.

Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

When using

Keep out of eyes, ears, or mouth.

Stop using

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

 In case of eye contact, flush eyes with water.

Children

Keep out of reach of children. 

Directions

Wet hands with water and dispense sufficient

    amount of product into cupped palm of hand.

Wash both hands thoroughly for 15 seconds.

Rinse under running water and dry thoroughly.

Inactive ingredients

Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water

Charm-Tex single label

Charm-Tex

Maximum Security

Anti-Bacterial Soap

1 GALLON

Drug Facts

Active Ingredient                                      Purpose

Parachlorometaxylenol 0.3% w/w……. Antiseptic

Uses

Handwash to help reduce bacteria on the skin that

   potentially can cause disease.

Recommended for repeated use.

Warnings

For external use only.

Keep out of eyes, ears, or mouth. In case of eye 

   contact, flush eyes with water.

Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

Directions

Wet hands with water and dispense sufficient

    amount of product into cupped palm of hand.

Wash both hands thoroughly for 15 seconds.

Rinse under running water and dry thoroughly.

Inactive ingredients Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water

MADE IN U.S.A.

CT-CTAB  Rev. 1.1                                                                                             H/CTAB 128

Charm Tex single label

Charm-Tex case label

Charm-Tex

Maximum Security

Anti-Bacterial Soap

4/1 GALLONG                                    MADE IN U.S.A.

CT-CTAB-CS Rev. 1.0                        H/CTAB 128

Charm-Tex case label

CHARMTEX ANTI BACTERIAL 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-406
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-406-013785 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/2018
2NDC: 58575-406-0215140 mL in 1 CASE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2018
Labeler - Inopak, Ltd. (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd.194718243manufacture(58575-406)

Revised: 10/2019
 
Inopak, Ltd.


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