HEAD AND SHOULDERS SMOOTH AND SILKY- pyrithione zinc lotion/shampoo 
ALL NATURAL DYNAMICS

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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Head & Shoulders smooth and silky

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

Directions

  • for best results use at least twice a week or as directed by a doctor.
  • for maximum dandruff control, use every time you shampoo.
  • wet hair, massage onto scalp, rinse, repeat if desired.

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

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

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, pyrithione zinc, blue 1, red 33.

Questions (or comments)?

01-800-717-2413

image description

HEAD AND SHOULDERS  SMOOTH AND SILKY
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51769-901
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (PYRITHIONE ZINC) Pyrithione Zinc0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sodium lauryl sulfate 
sodium laureth sulfate 
glycol distearate 
zinc carbonate 
sodium chloride 
sodium xylenesulfonate 
dimethicone 
COCO MONOETHANOLAMIDE 
sodium benzoate 
magnesium carbonate hydroxide 
methylchloroisothiazolinone 
methylisothiazolinone 
POLYQUATERNIUM-10 (400 MPA.S AT 2%) 
Cetyl Alcohol 
Magnesium Sulfate 
ALOE VERA LEAF 
Benzyl Alcohol 
Sodium Xylenesulfonate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51769-901-40400 mL in 1 BOTTLE, PLASTIC
2NDC:51769-901-70700 mL in 1 BOTTLE, PLASTIC
3NDC:51769-901-111000 mL in 1 BOTTLE, PLASTIC
4NDC:51769-901-181180 mL in 1 BOTTLE, PLASTIC
5NDC:51769-901-20200 mL in 1 BOTTLE, PLASTIC
6NDC:51769-901-0550 mL in 1 BOTTLE, PLASTIC
7NDC:51769-901-0110 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/24/2013
Labeler - ALL NATURAL DYNAMICS (962732892)
Establishment
NameAddressID/FEIBusiness Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.810007526manufacture(51769-901)

Revised: 1/2013
Document Id: ce990dd1-49a2-44d8-8564-d57c55600e87
Set id: bd4ed8cb-d06d-4247-b1d1-3b0ffa9c7fbc
Version: 1
Effective Time: 20130130
 
ALL NATURAL DYNAMICS