Label: CLEAR MEN COOL SPORT MINT ANTIDANDRUFF- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 64942-1286-1, 64942-1286-2, 64942-1286-3 - Packager: Conopco Inc. d/b/a Unilever
- 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 April 16, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients
Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroyl Isethionate, Carbomer, Dimethiconol, Menthol, Stearic Acid, Dimethicone, Sodium Chloride, Sodium Isethionate, DMDM Hydantoin, Hydrogenated Coconut Oil, Guar Hydroxypropyltrimonium Chloride, Citric Acid, Zinc Sulfate, TEA-Dodecylbenzenesulfonate, Tallow Acid, Poloxamer 407, Laureth-23, Butylene Glycol, Lysine HCl, Tocopheryl Acetate, Panthenol, PPG-9, Laureth-4, Iodopropynyl Butylcarbamate, PEG-4, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glycine Soja (Soybean) Oil, Methylchloroisothiazolinone, Methylisothiazolinone, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Panax Ginseng Root Extract, Mentha Viridis (Spearmint) Leaf Oil, Titanium Dioxide (CI 77891).
- QUESTIONS
- 16.1 FL. OZ. PDP
- 16.1 FL. OZ. back
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INGREDIENTS AND APPEARANCE
CLEAR MEN COOL SPORT MINT ANTIDANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64942-1286 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1.0 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM LAUROYL ISETHIONATE (UNII: M590021Z02) MENTHOL (UNII: L7T10EIP3A) DMDM HYDANTOIN (UNII: BYR0546TOW) TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) SUNFLOWER OIL (UNII: 3W1JG795YI) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PPG-9 (UNII: I29VQH0G0B) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SPEARMINT OIL (UNII: C3M81465G5) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) STEARIC ACID (UNII: 4ELV7Z65AP) ZINC SULFATE (UNII: 89DS0H96TB) DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM ISETHIONATE (UNII: 3R36J71C17) POLOXAMER 407 (UNII: TUF2IVW3M2) LAURETH-23 (UNII: N72LMW566G) LAURETH-4 (UNII: 6HQ855798J) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ALMOND OIL (UNII: 66YXD4DKO9) PANTHENOL (UNII: WV9CM0O67Z) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) SOYBEAN OIL (UNII: 241ATL177A) XANTHAN GUM (UNII: TTV12P4NEE) ASIAN GINSENG (UNII: CUQ3A77YXI) TEA TREE OIL (UNII: VIF565UC2G) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J) TALLOW ACID, BEEF (UNII: 5U9XZ261ER) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64942-1286-1 381 mL in 1 CONTAINER 2 NDC:64942-1286-2 647 mL in 1 CONTAINER 3 NDC:64942-1286-3 476 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/09/2012 Labeler - Conopco Inc. d/b/a Unilever (001375088) Establishment Name Address ID/FEI Business Operations Unilever Supply Chain Co. d/b/a Unilever 043510056 manufacture(64942-1286)