BLUE CAP CREAM- zinc pyrithione cream 
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 Cream

ACTIVE INGREDIENTS PURPOSE

Pyrithione Zinc 0.2%.................. Seborrheic Dermatitis

Box

Warnings

WARNINGS

  • For external use only.
  • Stop use and ask a doctor if rash occurs.
  • Do not use on damaged or broken skin
  • KEEP out of the reach of children

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

  • apply twice a day on affected area.
  • for best results use at least twice a week or as directed by the doctor

Uses

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 NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Cholesterol, Xanthan Gum, Diazolidinyl Urea, Sodium Methylparaben, Sodium Propylparaben, Citric Acid, Methylparaben, Propylparaben, Phosphoric Acid, Parfum

Uses

Package Label

Tube

BLUE CAP CREAM 
zinc pyrithione cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CERAMIDE AP (UNII: F1X8L2B00J)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCROSE COCOATE (UNII: 3H18P0UK73)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
LINALOOL, (-)- (UNII: 3U21E3V8I2)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
PROPANEDIOL (UNII: 5965N8W85T)  
GERANIOL (UNII: L837108USY)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LEVOMENOL (UNII: 24WE03BX2T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
.BETA.-CITRONELLOL, (S)- (UNII: 8RSY5Y5658)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
COUMARIN (UNII: A4VZ22K1WT)  
BENZYL BENZOATE (UNII: N863NB338G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64539-022-021 in 1 BOX11/25/2018
1NDC:64539-022-011 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/25/2018
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-022)

Revised: 11/2018
Document Id: 7b7fe22c-8a03-1bf2-e053-2991aa0a237c
Set id: 7d63dc56-27a6-0959-e053-2a91aa0a53c4
Version: 2
Effective Time: 20181125
 
Catalysis, SL