Label: FAMILY DOLLAR ANTIBACTERIAL HAND- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 55319-512-01, 55319-512-02 - Packager: Family Dollar Services Inc.
- 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 January 2, 2014
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- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of the reach of children
- Directions
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
FAMILY DOLLAR ANTIBACTERIAL HAND
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-512 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.15 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DMDM HYDANTOIN (UNII: BYR0546TOW) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-512-01 221 mL in 1 BOTTLE, PUMP 2 NDC:55319-512-02 1180 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/02/2014 Labeler - Family Dollar Services Inc. (024472631) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co.,Ltd. 529047265 manufacture(55319-512)