Label: CORALITE ULTRA ANTIBACTERIAL DEODORANT- triclocarban soap
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-807-35 - Packager: United Exchange Corp
- 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 30, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CORALITE ULTRA ANTIBACTERIAL DEODORANT
triclocarban soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-807 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN 0.3 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM COCOATE (UNII: R1TQH25F4I) SODIUM PALMATE (UNII: S0A6004K3Z) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PALM ACID (UNII: B6G0Y5Z616) PEG-6 METHYL ETHER (UNII: WXH089JZ5E) SORBITOL (UNII: 506T60A25R) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C YELLOW NO. 8 (UNII: 93X55PE38X) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-807-35 100 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/30/2014 Labeler - United Exchange Corp (840130579)