Blue Cap Spray

Drug Labeling and Warnings

Drug Details [pdf]

BLUE CAP- zinc pyrithione spray 
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 Spray

ACTIVE INGREDIENTS PURPOSE

Zync Pyrithione 0.19%.............Anti-Dandruff

Seborrheic Dermatitis

Warnings

• For external use only.
• Avoid contact with the eyes. If contact occurs, rinse throughly with water
• If conditions worsens or does not improve 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 a Poison Center inmediately

WARNINGS

• For external use only.
• Avoid contact with the eyes. If contact occurs, rinse throughly with water
• If conditions worsens or does not improve 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 a Poison 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

• Shake well before use. To be use in upright position. Apply 2-3 times a day to any affected area.
• For best results use at least twice a week or as directed by the doctor

• Shake well before use. To be use in upright position. Apply 2-3 times a day to any 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 dandruff and seborrheic dermatitis

Inactive Ingredients

Isopropyl Myristate, Alcohol, Isobutane, Propane, Bisabolol, Polysorbate 80, Zinc Pyrithione, Butane, Tocopheryl Acetate

Uses

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

Package Label

BLUE CAP 
zinc pyrithione spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64539-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.19 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPANE (UNII: T75W9911L6)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
BUTANE (UNII: 6LV4FOR43R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64539-023-02	1 in 1 BOX	11/25/2018
1	NDC: 64539-023-01	100 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	11/25/2018	01/01/2019

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Establishment
Name	Address	ID/FEI	Business Operations
Catalysis, SL		862795119	manufacture(64539-023)

Revised: 6/2019

Document Id: 8a53a731-28a3-090d-e053-2a95a90aa351

34390-5

Set id: 7d63e66d-2f75-5b48-e053-2991aa0ac0c2

Version: 5

Effective Time: 20190602

 

Catalysis, SL