HEAD AND SHOULDERS APPLE FRESH- 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 Apple Fresh

Purpose

Clean hair with a long-lasting and fresh aroma

*Up to 100% dandruff free

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

The DermaSense balanced pH formula, eliminates up to 100% of dandruff trace*, takes care of your scalp and leaves your hair

beautiful,

*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 Lauryl Sulfate, Sodium Laureth Sulfate, Glycol Distearate,

Dimethicone, Zinc Carbonate, Sodium Chloride, Sodium Xylenesulfonate,

Cocamidopropyl Betaine, Fragrance, Sodium Benzoate, Guar

Hydroxypropyltrimonium Chloride, Hydrochloric Acid,

Magnesium Carbonate Hydroxide, Hexyl Cinnamal, FD&C Yellow No. 5, Methylchloroisothiazolinone,

FD&C Blue 1 and 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 APPLE FRESH

APPLE FRESH APPLE FRESH

HEAD AND SHOULDERS APPLE FRESH 
head and shoulders lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72389-104
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
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)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72389-104-02375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/2018
2NDC:72389-104-03180 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(72389-104)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.812839648label(72389-104)

Revised: 1/2022
Document Id: d5928444-9390-2dc8-e053-2a95a90a44dd
Set id: 76e04d47-3dfa-eea7-e053-2991aa0a14fa
Version: 2
Effective Time: 20220114
 
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.