Label: SKIN CLEANSER- chloroxylenol soap
- NDC Code(s): 65601-865-04, 65601-865-06, 65601-865-55
- Packager: Betco Corporation, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 16, 2020
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- Official Label (Printer Friendly)
- Medicated Lotion Skin Cleanser
- Knuckle Under Medicated
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Knuckle Under Medicated
Warnings
- For external use only.
- Avoid contact with eyes.
- If contact occurs, rinse thoroughly with water.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
- If swallowed, get medical help or contact a poison control center right away.
- Knuckle Under Medicated
- Knuckle Under Medicated
- Knuckle Under Medicated
- Knuckle Under Medicated
- Medicated Lotion Skin Cleanser
-
INGREDIENTS AND APPEARANCE
SKIN CLEANSER
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-865 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD) METHYL ALCOHOL (UNII: Y4S76JWI15) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) EDETATE SODIUM (UNII: MP1J8420LU) TALL OIL ACID (UNII: H9HR63474M) ALCOHOL (UNII: 3K9958V90M) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) SODIUM CHLORIDE (UNII: 451W47IQ8X) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DIISOPROPANOLAMINE (UNII: 0W44HYL8T5) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) CALCIUM SILICATE (UNII: S4255P4G5M) FORMALDEHYDE (UNII: 1HG84L3525) DIOXANE (UNII: J8A3S10O7S) SODIUM FERROCYANIDE (UNII: 5HT6X21AID) SODIUM CARBONATE (UNII: 45P3261C7T) SODIUM GLYCOLATE (UNII: B75E535IMI) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-865-04 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2016 2 NDC:65601-865-06 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/12/2012 3 NDC:65601-865-55 208000 mL in 1 DRUM; Type 0: Not a Combination Product 11/12/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/12/2012 Labeler - Betco Corporation, Ltd. (024492831) Registrant - Betco corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(65601-865) , label(65601-865) , pack(65601-865)
