Label: ANTIBACTERIAL HAND- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-0100-0 - Packager: Greenbrier International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 5, 2012
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- Official Label (Printer Friendly)
- Antibacterial Hand Soap
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Antibacterial Hand Soap 16oz/500ml (33992-0100-0)
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0100-0 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 12/05/2012 Labeler - Greenbrier International, Inc. (610322518) Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956) Establishment Name Address ID/FEI Business Operations Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture(33992-0100)