Your browser does not support JavaScript! HEAD AND SHOULDERS BREAKAGE PREVENTION (PYRITHIONE ZINC) SHAMPOO [ALL NATURAL DYNAMICS]
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HEAD AND SHOULDERS BREAKAGE PREVENTION (pyrithione zinc) shampoo
[ALL NATURAL DYNAMICS]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51769-141
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 laureth sulfate 
Sodium lauryl sulfate 
Coco Monoethanolamide 
Zinc carbonate 
Glycol distearate 
Dimethicone 
Guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) 
Magnesium sulfate 
Sodium benzoate 
magnesium carbonate hydroxide 
Benzyl alcohol 
.ALPHA.-TOCOPHEROL ACETATE 
FD&C Yellow No. 5 
methylchloroisothiazolinone 
methylisothiazolinone 
FD&C Blue no. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51769-141-50500 mL in 1 BOTTLE, PLASTIC
2NDC:51769-141-40400 mL in 1 BOTTLE, PLASTIC
3NDC:51769-141-20200 mL in 1 BOTTLE, PLASTIC
4NDC:51769-141-111000 mL in 1 BOTTLE, PLASTIC
5NDC:51769-141-181180 mL in 1 BOTTLE, PLASTIC
6NDC:51769-141-0550 mL in 1 BOTTLE, PLASTIC
7NDC:51769-141-0110 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/01/2013
Labeler - ALL NATURAL DYNAMICS (962732892)
Establishment
NameAddressID/FEIBusiness Operations
Procter & Gamble Manufactura, S. de R.L. de C.V.812807550manufacture(51769-141)

Revised: 2/2013
 
ALL NATURAL DYNAMICS

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