BLUE CAP CREAM- zinc pyrithione cream

Blue Cap Cream by

Drug Labeling and Warnings

Blue Cap Cream by is a Otc medication manufactured, distributed, or labeled by Catalysis, SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS PURPOSE

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

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

• 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

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

Uses

• For the relief of the symptons of seborrheic dermatitis

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

• For the relief of the symptons of seborrheic dermatitis

Package Label

INGREDIENTS AND APPEARANCE

BLUE CAP CREAM 
zinc pyrithione cream

Product 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)