HEAD AND SHOULDERS BREAKAGE PREVENTION- pyrithione zinc 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 and Shoulders breakage prevention

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

helps prevent hair loss

Warnings

For external use only.

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.

Directions

Inactive ingredients

Water, Sodium laureth sulfate, Sodium lauryl sulfate, Coco Monoethanolamide, Zinc carbonate, Glycol distearate, Dimethicone, Guar hydroxypropyltrimonium chloride, Magnesium sulfate, Sodium benzoate, Magnesium carbonate hydroxide, Benzyl alcohol, Tocopheryl acetate, FD&C Yellow No. 5, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue no. 1

Questions (or comments)?

01-800-717-2413

Dist. by

Procter & Gamble Manufactura, S. de R.L. de C.V.

San Andr`s Atoto No. 326, Naucalpan de Juarez,

Estado de Mexico, MX

www.headandshoulders.com

image description

HEAD AND SHOULDERS  BREAKAGE PREVENTION
pyrithione zinc shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51769-141
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 laureth sulfate (UNII: BPV390UAP0)  
Sodium lauryl sulfate (UNII: 368GB5141J)  
Coco Monoethanolamide (UNII: C80684146D)  
Zinc carbonate (UNII: EQR32Y7H0M)  
Glycol distearate (UNII: 13W7MDN21W)  
Dimethicone (UNII: 92RU3N3Y1O)  
Guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) (UNII: B16G315W7A)  
Magnesium sulfate (UNII: DE08037SAB)  
Sodium benzoate (UNII: OJ245FE5EU)  
magnesium carbonate hydroxide (UNII: YQO029V1L4)  
Benzyl alcohol (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C Yellow No. 5 (UNII: I753WB2F1M)  
methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
methylisothiazolinone (UNII: 229D0E1QFA)  
FD&C Blue no. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51769-141-50 500 mL in 1 BOTTLE, PLASTIC
2 NDC:51769-141-40 400 mL in 1 BOTTLE, PLASTIC
3 NDC:51769-141-20 200 mL in 1 BOTTLE, PLASTIC
4 NDC:51769-141-11 1000 mL in 1 BOTTLE, PLASTIC
5 NDC:51769-141-18 1180 mL in 1 BOTTLE, PLASTIC
6 NDC:51769-141-05 50 mL in 1 BOTTLE, PLASTIC
7 NDC:51769-141-01 10 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 02/01/2013
Labeler - ALL NATURAL DYNAMICS (962732892)
Establishment
Name Address ID/FEI Business Operations
Procter & Gamble Manufactura, S. de R.L. de C.V. 812807550 manufacture(51769-141)

Revised: 2/2013
Document Id: f58016ec-c5ab-4943-bd2b-e85b04fac313
Set id: 35efb2a7-b707-4fe1-9a45-0b280aac7618
Version: 1
Effective Time: 20130201
 
ALL NATURAL DYNAMICS