Label: DERMAPROT TRICLOTREX-B- triclosan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66854-004-01 - Packager: SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
- Category: HUMAN PRESCRIPTION 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 August 5, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMAPROT TRICLOTREX-B
triclosan liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66854-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.3 mg in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIPYRITHIONE (UNII: 9L87N86R9A) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66854-004-01 500 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/30/2012 Labeler - SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184) Establishment Name Address ID/FEI Business Operations SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS 880172184 manufacture(66854-004) , analysis(66854-004) , label(66854-004) , pack(66854-004)