Label: CLEAR MEN OCEAN MINERAL ANTIDANDRUFF- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 64942-1312-1 - 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 September 25, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
CLEAR MEN OCEAN MINERAL ANTIDANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64942-1312 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) 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) POLYETHYLENE GLYCOL 400000 (UNII: 439X29GCJZ) 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O) SPIRULINA MAXIMA (UNII: 9K7IG15M0Q) MENTHA AQUATICA LEAF (UNII: 5M106ME6PT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64942-1312-1 381 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/01/2013 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(64942-1312)