HEAD AND SHOULDERS RENEWING CLEAN- 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 and Shoulders renewing clean

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.

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, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

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  RENEWING CLEAN
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51769-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc0.01 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
sodium chloride (UNII: 451W47IQ8X)  
methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
methylisothiazolinone (UNII: 229D0E1QFA)  
sodium xylenesulfonate (UNII: G4LZF950UR)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51769-139-40400 mL in 1 BOTTLE, PLASTIC
2NDC:51769-139-50500 mL in 1 BOTTLE, PLASTIC
3NDC:51769-139-20200 mL in 1 BOTTLE, PLASTIC
4NDC:51769-139-70700 mL in 1 BOTTLE, PLASTIC
5NDC:51769-139-111000 mL in 1 BOTTLE, PLASTIC
6NDC:51769-139-181180 mL in 1 BOTTLE, PLASTIC
7NDC:51769-139-0550 mL in 1 BOTTLE, PLASTIC
8NDC:51769-139-0110 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/29/2013
Labeler - ALL NATURAL DYNAMICS (962732892)
Establishment
NameAddressID/FEIBusiness Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.810007526manufacture(51769-139)

Revised: 1/2013
Document Id: bee61e39-5dbe-4dc0-b6bd-d753fe128346
Set id: d5d3eea1-e97d-4d63-9329-35e38ece507a
Version: 1
Effective Time: 20130129
 
ALL NATURAL DYNAMICS