BLADE HOWL ANTI-DANDRUFF- pyrithione zinc shampoo 
CVS PHARMACY INC

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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Drug Facts Box

Active Ingredient

Pyrithione Zinc 1%

Purpose

Antidandruff

Uses

To help prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only.

when using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop using this product and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

For maximum dandruff control, use every time you shampoo. Wet hair, massage onto scalp and rinse . Repeat if desired.

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Polyquaternium-7, Cocamide MEA, Glycol Distearate, Cocamidopropyl Betaine, Fragrance (Parfum), Dimethicone, Sodium Chloride, Tetrasodium EDTA, Sodium Hydroxide, Citric Acid  DMDM Hydantoin, Blue 1 (CI 42090), Red 33 (CI 17200).

Package Front and Back Labels

blade.jpg12 OZ Front and Bakc labels

BLADE HOWL  ANTI-DANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-422-12355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/03/2010
Labeler - CVS PHARMACY INC (062312574)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 11/2010
Document Id: af0fba1d-8dc3-4f1e-89e3-db97c30d25d1
Set id: 36415ce4-b737-4aeb-9331-a9230dd78bfa
Version: 1
Effective Time: 20101103
 
CVS PHARMACY INC