Label: TOPCARE MEDICATED DANDRUFF- selenium sulfide shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-610-11 - Packager: Topco Associates LLC
- 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 September 29, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
- FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
- AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.
- FOR EXTERNAL USE ONLY.
- USE
- DIRECTIONS
- INACTIVE INGREDIENTS
- PACKAGE FRONT AND BACK LABELS
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INGREDIENTS AND APPEARANCE
TOPCARE MEDICATED DANDRUFF
selenium sulfide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE 1 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA) AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) MENTHOL (UNII: L7T10EIP3A) COCO DIETHANOLAMIDE (UNII: 92005F972D) DMDM HYDANTOIN (UNII: BYR0546TOW) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-610-11 325 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/29/2010 Labeler - Topco Associates LLC (006935977)