HEAD AND SHOULDER MEN OLD SPICE- 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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DRUGS FACTS

ACTIVE INGREDIENTS

Pyrithione zinc 1%

PURPOSE

Anti-dandruff

USES

Help prevent recurrence of flaking and itching associated with dan druff

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 procuct as directed.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a poison control center rigth away.

DIRECTIONS

WATER, SODIUM LAURYL SULFATE, SODIUM LAURETH SULDATE, GLYCOL DISTEARATE , ZINC CARBONATE, SODIUM CHLORIDE, SODIUM XYLENESULFONATE, COCAMIDOPROPYL BETAINE, FRAGANCE, DIMETHICONE, SODIUM BENZOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1, RED 33

HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

pyrithione zincHEAD AND SHOULDERS MEN OLD SPICE

HEAD AND SHOULDER  MEN OLD SPICE
pyrithione zinc lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51769-427
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.01 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51769-427-01650 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/10/2022
Labeler - All Natural Dynamics (962732892)
Registrant - All Natural Dynamics (962732892)
Establishment
NameAddressID/FEIBusiness Operations
Procter and Gamble Manufacturara SA De CV812807550manufacture(51769-427)

Revised: 5/2022
Document Id: deb250d1-e9cc-ce20-e053-2a95a90a2f8d
Set id: deb250bb-4019-024a-e053-2995a90ac5b4
Version: 2
Effective Time: 20220510
 
All Natural Dynamics