HEAD AND SHOULDERS REFRESHING RELIEF- head and shoulders lotion/shampoo

HEAD AND SHOULDERS REFRESHING RELIEF by

Drug Labeling and Warnings

HEAD AND SHOULDERS REFRESHING RELIEF 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

With refreshing ingredients for immediate sensation

*up to 100% dandruff free

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

Head and Shoulders Refreshing Relief with balanced PH contains ingredients that in contact with the skin unleash refreshing sensations that immediate reduce the itching related to dandruff

*Visible dandruff, using it often.

Active Ingredient

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

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

Indications:

helps prevent recurrence of flaking and itching associated with 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, Cocamide MEA, Zinc Carbonate,

Glycol distearate,sodium xylenesulfonate, Fragrance, Dimethicone, Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride,

Hydrochloric Acid, Magnesium Sulfate, Sodium Chloride, Sodium Benzoate, Magnesium Carbonate Hydroxide,

Hexyl Cinnamal, Benzyl Alcohol, Mentha Piperita Oil, Menthol, Mentha arvensis leaf oil, Hydroxycitronellal, Linalool,

FD&C Yellow No. 5, Methylisothiaolinone, FD&C Blue No. 1

Distributed by:

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

Made in Mexico

HEAD & SHOULDERS Antidandruff Shampoo REFRESHING RELIEF

Refreshing Relief

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS REFRESHING RELIEF 
head and shoulders lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72389-108
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
LINALOOL, (-)- (UNII: 3U21E3V8I2)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
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)
CETYL ALCOHOL (UNII: 936JST6JCN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72389-108-02	375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/27/2018
2	NDC: 72389-108-03	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(72389-108)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA DISTRIBUCIONES INTERNACIONALES, S.A. DE C.V.		812839648	label(72389-108)