BLUE CAP- zinc pyrithione shampoo

Blue Cap by

Drug Labeling and Warnings

Blue Cap 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 1%.................. Anti dandruff/ Seborrheic Dermatitis

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 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

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

Package Label

INGREDIENTS AND APPEARANCE

BLUE CAP 
zinc pyrithione shampoo

Product 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)