Blue Cap Shampoo

Drug Labeling and Warnings

Drug Details [pdf]

BLUE CAP- zinc pyrithione shampoo 
Catalysis, SL

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.

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Blue Cap Shampoo

ACTIVE INGREDIENTS PURPOSE

Pyrithione Zinc 1%.................. Anti dandruff/ Seborrheic Dermatitis

Box

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.

Warnings

Keep out of reach of children

Questions or comments?

+ 34 91 345 6902 M-F 9:00 am to 5:00 pm

Other Information

. keep the product in a cool and dry place

Directions

  • Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water.
  • For best results use at least twice a week or as directed by the doctor

  • Wet hair. Apply a small amount quantity of the product into hair and massage the scalp. Rinse and repeat the application. Allow the product to act for 5 minutes. Rinse throughly with enough water.
  • For best results use at least twice a week or as directed by the doctor

Uses

  • For the relief of the symptons of dandruff and seborrheic dermatitis

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 NP, 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

  • For the relief of the symptons of dandruff and seborrheic dermatitis

Package Label

Bottle

BLUE CAP 
zinc pyrithione shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64539-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 NP (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64539-024-021 in 1 BOX11/25/2018
1NDC: 64539-024-01150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/25/201801/01/2019
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-024)

Revised: 6/2019
 
Catalysis, SL