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

Box

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

Tube

BLUE CAP 
zinc pyrithione spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64539-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.19 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64539-023-021 in 1 BOX11/25/2018
1NDC: 64539-023-01100 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(64539-023)

Revised: 6/2019
 
Catalysis, SL