Label: MEDI-HANDS- chloroxylenol soap
- NDC Code(s): 68978-141-04
- Packager: Topmost Chemical & Paper Corporation
- 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 May 3, 2019
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- Medi-Hands Pearlized Antibacterial Skin Cleanser with PCMX Distributed by: TOPMOST CHEMICAL & PAPER CORP. 3394 Winchester Rd. Memphis, TN 38118 (901) 363-7278
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INGREDIENTS AND APPEARANCE
MEDI-HANDS
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68978-141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO DIETHANOLAMIDE (UNII: 92005F972D) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCOL STEARATE (UNII: 0324G66D0E) LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38) GLYCERIN (UNII: PDC6A3C0OX) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68978-141-04 3780 mL in 1 JUG; Type 0: Not a Combination Product 05/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/06/2014 Labeler - Topmost Chemical & Paper Corporation (086944576) Registrant - Betco corporation, Ltd. (005050158) Establishment Name Address ID/FEI Business Operations Betco Corpo, Ltd. 005050158 manufacture(68978-141) , pack(68978-141) , label(68978-141)