HEAD AND SHOULDERS 2 IN 1 INSTANT MOISTURIZATION- head and shoulders lotion/shampoo 
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.

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 2 in 1 INSTANT MOISTURIZATION

Purpose

Feel your hair and scalp instantly moisturized

*Up to 100% dandruff free

With Regular use, H&S' 3action formula cleans, protects and hydrates hair and scalp.

Head and Shoulders Instant Moisturization with balanced PH contains ingredients that upon contact with the skin create a moisture mesh that help immediately nourish hair and scalp.

Additionally, its formula leaves your hair up to 100% free of dandruff*

*Visible dandruff, using it often.

Active Ingredient

Active Ingredient................................................................................Purpose

Pyrithione Zinc 1%.....................................................................Anti-dandruff

Warnings

for external use only.

When using this product

-do not get into eyes. If contact occurs, rinse thoroughly with water

Stop use and ask doctor if

condition worsens or does not improve after regular use as directed

Keep our of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

-shake well before use - apply in wet hair - massage into scalp - rinse

-repeat as desired

-for best results use at least twice a week or as directed by a doctor

-for maximum dandruff control, use every time you shampoo

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Dimethicone, Cocamide MEA, Zinc Carbonate, Glycol Distearate, Sodium Xylenesulfonate, Cetyl Alcohol, Fragrance, Guar Hydroxypropyltrimonium Chloride, Hydrochloric Acid, Magnesium Sulfate, Sodium Chloride, Sodium Benzoate, Linalool, Magnesium Carbonate Hydroxide, Benzyl Alcohol, Hexyl Cinnamal, Benzyl Salicylate, Prunus amygdalus dulcis oil, Methylchloroisothiazolinone, Methylisothiaolinone

Distributed by:

ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.

Made in Mexico

Indications:

helps prevent recurrence of flaking and itching associated with dandruff

Principal Display Panel Antidandruff Shampoo 2 in 1
INSTANT MOISTURIZATION

INSTANT MOISTURIZATION INSTANT MOITURIZATON

HEAD AND SHOULDERS 2 IN 1 INSTANT MOISTURIZATION 
head and shoulders lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72389-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALMOND OIL (UNII: 66YXD4DKO9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72389-105-02375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/27/2018
Labeler - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (812839648)
Registrant - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (815333653)
Establishment
NameAddressID/FEIBusiness Operations
PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V.812807550manufacture(72389-105)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.812839648label(72389-105)

Revised: 1/2022
Document Id: d59270a1-8c34-f984-e053-2995a90a8dc7
Set id: 76e30658-9d40-e0df-e053-2a91aa0a855d
Version: 2
Effective Time: 20220114
 
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.