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

When using this product

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51769-901
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc 0.01 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
sodium lauryl sulfate (UNII: 368GB5141J)  
sodium laureth sulfate (UNII: BPV390UAP0)  
glycol distearate (UNII: 13W7MDN21W)  
zinc carbonate (UNII: EQR32Y7H0M)  
sodium chloride (UNII: 451W47IQ8X)  
dimethicone (UNII: 92RU3N3Y1O)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
sodium benzoate (UNII: OJ245FE5EU)  
magnesium carbonate hydroxide (UNII: YQO029V1L4)  
methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
methylisothiazolinone (UNII: 229D0E1QFA)  
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Magnesium Sulfate (UNII: DE08037SAB)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Sodium Xylenesulfonate (UNII: G4LZF950UR)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51769-901-40 400 mL in 1 BOTTLE, PLASTIC
2 NDC:51769-901-70 700 mL in 1 BOTTLE, PLASTIC
3 NDC:51769-901-11 1000 mL in 1 BOTTLE, PLASTIC
4 NDC:51769-901-18 1180 mL in 1 BOTTLE, PLASTIC
5 NDC:51769-901-20 200 mL in 1 BOTTLE, PLASTIC
6 NDC:51769-901-05 50 mL in 1 BOTTLE, PLASTIC
7 NDC:51769-901-01 10 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 01/24/2013
Labeler - ALL NATURAL DYNAMICS (962732892)
Establishment
Name Address ID/FEI Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V. 810007526 manufacture(51769-901)

Revised: 12/2013
Document Id: 9f63604f-8dae-449c-87eb-a2ba10617f14
Set id: bd4ed8cb-d06d-4247-b1d1-3b0ffa9c7fbc
Version: 2
Effective Time: 20131212
 
ALL NATURAL DYNAMICS