Label: ANTIBACTERIAL HAND- antiseptic hand soap soap
- NDC Code(s): 61307-060-09
- Packager: US Chemical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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Drug Label Information
Updated January 31, 2022
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND
antiseptic hand soap soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61307-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength TALL OIL ACID (UNII: H9HR63474M) COCONUT ACID (UNII: 40U37V505D) ACID RED 35 (UNII: 02BXM5Q7GE) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) WATER (UNII: 059QF0KO0R) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SODIUM SULFATE (UNII: 0YPR65R21J) DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) ALOE VERA LEAF (UNII: ZY81Z83H0X) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61307-060-09 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/13/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/13/2013 Labeler - US Chemical Corporation (031457842) Registrant - Kutol Products Company (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company 004236139 manufacture(61307-060)