Label: ANTI-BACTERIAL FRESH ALOE HAND- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 53603-2015-8 - Packager: BB17, LLC
- 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 August 20, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:Water, Sodium Alkyl Ether Sulphate, Ammonium Lauryl Sulphate, Cocamidopropyl Betaine, Cocamide DEA, Disodium Laureth Sulfosuccinate, Sodium Chloride, Glycol Distearate, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, Disodium EDTA, FD&C Yellow NO. 5, FD&C Blue NO. 1
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-BACTERIAL FRESH ALOE HAND
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53603-2015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C12-15 PARETH-3 SULFATE (UNII: 19Q4RW8UWP) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCOL DISTEARATE (UNII: 13W7MDN21W) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53603-2015-8 236.6 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/20/2013 Labeler - BB17, LLC (828378294)