Label: BLUE CAP- zinc pyrithione shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 64539-020-01, 64539-020-02 - 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 September 13, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS PURPOSE
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Warnings
- For external use only.
- Avoid contact with the eyes. If contact occurs rinse the eyes throughly with water
- If conditions worsens or does not improves after regular use of this product as directed, consult with a doctor
- When using this product
- KEEP out of the reach of children. In case of overdose get medical help or contact the Poison Control Center inmediately.
WARNINGS
- For external use only.
- Avoid contact with the eyes. If contact occurs rinse the eyes throughly with water
- If conditions worsens or does not improves after regular use of this product as directed, consult with a doctor
- When using this product
- KEEP out of the reach of children. In case of overdose get medical help or contact the Poison Control Center inmediately.
- Questions or comments?
- Other Information
- Directions
- Uses
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Inactive Ingredients
Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Zinc Pyrithione, Alcohol Denat, Sodium Chloride, Menthol, Glycol Distearate, PEG/PPG-20/6 Dimethicone, Tocopheryl Acetate, Sodium Hydroxide, Steareth-4, Sodium Lauroyl Lactylate, Disodium EDTA, Propylene Glycol, Phenoxyethanol, Ceramide 3, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Carbomer, Xanthan Gum, Ethylhexylglycerin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Diazolidinyl Urea, Sodium Benzoate, Potassium Sorbate, Methylchloroisothiazolinone, Methylisothiazolinone, Methylparaben, Propylparaben, Triisopropanolamine, Hexyl Cinnamal, Limonene, Benzyl Salicylate
- Uses
- Package Label
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INGREDIENTS AND APPEARANCE
BLUE CAP
zinc pyrithione shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64539-020 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 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPANEDIOL (UNII: 5965N8W85T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) CERAMIDE AP (UNII: F1X8L2B00J) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) ALCOHOL (UNII: 3K9958V90M) SODIUM CHLORIDE (UNII: 451W47IQ8X) MENTHOL (UNII: L7T10EIP3A) GLYCOL DISTEARATE (UNII: 13W7MDN21W) PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARETH-4 (UNII: 1VBG09S3UL) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CERAMIDE 3 (UNII: 4370DF050B) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) XANTHAN GUM (UNII: TTV12P4NEE) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL SALICYLATE (UNII: WAO5MNK9TU) LIMONENE, (+)- (UNII: GFD7C86Q1W) CERAMIDE 1 (UNII: 5THT33P7X7) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64539-020-02 1 in 1 BOX 07/30/2018 1 NDC:64539-020-01 150 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 07/30/2018 Labeler - Catalysis, SL (862795119) Registrant - Catalysis, SL (862795119) Establishment Name Address ID/FEI Business Operations Catalysis, SL 862795119 manufacture(64539-020)