KROGER MEDICATED DANDRUFF- selenium sulfide liquid

KROGER by

Drug Labeling and Warnings

KROGER by is a Otc medication manufactured, distributed, or labeled by THE KROGER COMPANY, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SELENIUM SULFIDE 1%

PURPOSE

ANTI-DANDRUFF/ANTI-SEBORRHEIC DERMATITIS

USES

FOR THE RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

WARNINGS

FOR EXTERNAL USE ONLY

ASK A DOCTOR BEFORE USE IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY

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. (1-800-222-1222)

DIRECTIONS

SHAKE WELL, APPLY SHAMPOO AND RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM LAURETH SULFATE, TEA-LAURYL SULFATE, COCAMIDOPROPYL BETAINE, ACRYLATES COPOLYMER, CITRIC ACID, FRAGRANCE, AMMONIUM CHLORIDE, DMDM HYDANTOIN, MENTHOL, SODIUM HYDROXIDE, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200)

QUESTIONS OR COMMENTS?

1-800-632-6900

LABEL COPY

INGREDIENTS AND APPEARANCE

KROGER  MEDICATED DANDRUFF
selenium sulfide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-519
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
TEA-LAURYL SULFATE (UNII: E8458C1KAA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MENTHOL (UNII: L7T10EIP3A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
HYPROMELLOSES (UNII: 3NXW29V3WO)
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: 30142-519-11	325 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/24/2014

Labeler - THE KROGER COMPANY (006999528)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(30142-519)