Label: BLUE CAP CREAM- zinc pyrithione cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64539-019-01, 64539-019-02 - Packager: Catalysis, SL
- 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 July 29, 2018
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- ACTIVE INGREDIENTS PURPOSE
- Warnings
- Questions or comments?
- Other Information
- Directions
- Uses
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Inactive Ingredients
Aqua, Isopropyl Palmitate, Diethylhexyl Carbonate, Sucrose Cocoate, Polyglyceryl-3 Methylglucose Distearate, Glycerin, Cyclopentasiloxane, Glyceryl Stearate. Zinc Pyrithione. Tocopheryl Acetate, Stearyl Alcohol, Methyl Gluceth-20, BHT, BHA, Propylene Glycol, Bisabolol, Carbomer, Sodium Lauroyl Lactylate, Ceramide 3, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Xanthan Gum, Diazolidinyl Urea, Sodium Methylparaben, Sodium Propylparaben, Farnesol, Citric Acid, Methylparaben, Propylparaben, Phosphoric Acid, Parfum
- Uses
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INGREDIENTS AND APPEARANCE
BLUE CAP CREAM
zinc pyrithione creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64539-019 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.24 mg in 1 mL CERAMIDE AP (UNII: F1X8L2B00J) 0.01 mg in 1 mL WATER (UNII: 059QF0KO0R) 63.02 mg in 1 mL ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 10 mg in 1 mL DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) 9 mg in 1 mL SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) 0.2 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 3 mg in 1 mL SUCROSE COCOATE (UNII: 3H18P0UK73) 3.25 mg in 1 mL POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) 3.2 mg in 1 mL CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 2 mg in 1 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1.4 mg in 1 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 mg in 1 mL STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 0.6 mg in 1 mL METHYL GLUCETH-20 (UNII: J3QD0LD11P) 0.5 mg in 1 mL LINALOOL, (-)- (UNII: 3U21E3V8I2) 0.1 mg in 1 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.5 mg in 1 mL BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) 0.5 mg in 1 mL PROPANEDIOL (UNII: 5965N8W85T) 0.5 mg in 1 mL GERANIOL (UNII: L837108USY) 0.1 mg in 1 mL HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) 0.1 mg in 1 mL LEVOMENOL (UNII: 24WE03BX2T) 0.445 mg in 1 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.05 mg in 1 mL CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.206 mg in 1 mL CERAMIDE 3 (UNII: 4370DF050B) 0.02 mg in 1 mL CERAMIDE 1 (UNII: 5THT33P7X7) 0.00002 mg in 1 mL PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) 0.01 mg in 1 mL CHOLESTEROL (UNII: 97C5T2UQ7J) 0.01 mg in 1 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.006 mg in 1 mL METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) 0.2 mg in 1 mL PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) 0.1 mg in 1 mL FARNESOL (UNII: EB41QIU6JL) 0.055 mg in 1 mL METHYLPARABEN (UNII: A2I8C7HI9T) 0.094 mg in 1 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.0268 mg in 1 mL PHOSPHORIC ACID (UNII: E4GA8884NN) 0.0012 mg in 1 mL .BETA.-CITRONELLOL, (S)- (UNII: 8RSY5Y5658) 0.1 mg in 1 mL BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.1 mg in 1 mL COUMARIN (UNII: A4VZ22K1WT) 0.1 mg in 1 mL BENZYL BENZOATE (UNII: N863NB338G) 0.1 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64539-019-02 1 in 1 BOX 07/29/2018 1 NDC:64539-019-01 56 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/29/2018 Labeler - Catalysis, SL (862795119) Registrant - Catalysis, SL (862795119) Establishment Name Address ID/FEI Business Operations Catalysis, SL 862795119 manufacture(64539-019)
