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Name:Blade Howlanti-dandruff
Manufacturer:Cvs Pharmacy Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts Box

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

../images_otc/blade_howlan_blade.jpg12 OZ Front and Bakc labels


BLADE HOWL  ANTI-DANDRUFF
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-422
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 1 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM LAURETH SULFATE  
AMMONIO METHACRYLATE COPOLYMER TYPE A  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
COCO MONOETHANOLAMIDE  
GLYCOL DISTEARATE  
COCAMIDOPROPYL BETAINE  
DIMETHICONE  
SODIUM CHLORIDE  
EDETATE SODIUM  
SODIUM HYDROXIDE  
CITRIC ACID MONOHYDRATE  
DMDM HYDANTOIN  
FD&C BLUE NO. 1  
D&C RED NO. 33  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-422-12 355 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 11/03/2010

Labeler - CVS PHARMACY INC (062312574)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture

Revised: 11/2010 CVS PHARMACY INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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