MEMBERS MARK GENTLE DANDRUFF- pyrithione zinc shampoo

MEMBERS MARK GENTLE DANDRUFF by

Drug Labeling and Warnings

MEMBERS MARK GENTLE DANDRUFF by is a Otc medication manufactured, distributed, or labeled by SAMS WEST INC, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

to help prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only.

When using this product

avoid contact with 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.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• for maximum dandruff control, use every time you shampoo.
• wet hair, massage onto scalp and rinse.
• repeat if desired.

Inactive ingredients

Water (Aqua), Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Glycol Distearate, Zinc Carbonate, Sodium Chloride, Sodium Xylenesulfonate, Dimethicone, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

INGREDIENTS AND APPEARANCE

MEMBERS MARK GENTLE DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-427
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 LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-427-40	1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 68196-427-41	1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/16/2016

Labeler - SAMS WEST INC (051957769)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(68196-427)