HEAD AND SHOULDERS APPLE FRESH- head and shoulders lotion/shampoo

HEAD AND SHOULDERS APPLE FRESH by

Drug Labeling and Warnings

HEAD AND SHOULDERS APPLE FRESH by is a Otc medication manufactured, distributed, or labeled by ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V., PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS APPLE FRESH 
head and shoulders lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72389-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72389-104-02	375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/27/2018
2	NDC: 72389-104-03	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/27/2018

Labeler - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (812839648)

Registrant - ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V. (815333653)

Establishment
Name	Address	ID/FEI	Business Operations
PROCTER & GAMBLE MANUFACTURING MEXICO, S. DE R.L. DE C.V.		812807550	manufacture(72389-104)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.		812839648	label(72389-104)