EQUATE MENS ULTRA SPORT 2 IN 1 DANDRUFF SH AND COND ANTI-DANDRUFF- pyrithione zinc shampoo

Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND by

Drug Labeling and Warnings

Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Garcoa, Inc., Sigan America, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only

When using this product

• ⬥ avoid contact with the 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 product as directed

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• ⬥ shake well
• ⬥ wet hair
• ⬥ massage onto scalp
• ⬥ rinse
• ⬥ repeat if 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

Other information

store at room temperature

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, sodium xylenesulfonate, sodium chloride, fragrance, magnesium sulfate, glycol distearate, benzyl alcohol, cetyl alcohol, citric acid, guar hydroxypropyltrimonium chloride, dimethicone, sodium benzoate, polyquaternium-10, ammonium laureth sulfate, camphor, menthol, methylchloroisothiazolinone, magnesium carbonate hydroxide, blue 1, red 33, methylisothiazolinone.

Questions or comments?

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SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 928.5 mL Bottle Label

NDC: 79903-003-01

equate™

Compare
to Head &
Shoulders®
active
ingredient*

MEN'S
Ultra Sport

2-in-1

Dandruff Shampoo &
Conditioner

With Pyrithione Zinc

• Advanced formula helps improve
  the health of hair and scalp
• Clean lemon-lime scent

31.4 FL OZ (928.5mL)

05-4129

INGREDIENTS AND APPEARANCE

EQUATE MENS ULTRA SPORT 2 IN 1 DANDRUFF SH AND COND   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
Sodium Chloride (UNII: 451W47IQ8X)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
Glycol Distearate (UNII: 13W7MDN21W)
Benzyl Alcohol (UNII: LKG8494WBH)
Cetyl Alcohol (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium Benzoate (UNII: OJ245FE5EU)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
Methylisothiazolinone (UNII: 229D0E1QFA)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-003-01	928.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	11/05/2020

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(79903-003)