FRUITOPIA- pyrithione zinc liquid

FRUITOPIA by

Drug Labeling and Warnings

FRUITOPIA by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PYRITHIONE ZINC 1%

PURPOSE

ANTI-DANDRUFF

USES

FOR RELIEF OF FLAKING, AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RE-OCCURENCE.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT 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

APPLY SHAMPOO ON WET HAIR, RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

QUESTIONS? COMMENTS?

1-866-428-7327

INACTIVE INGREDIENTS

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, DIMETHICONE, CITRIC ACID, SODIUM CITRATE, AMMONIUM XYLENESULFONATE, COCAMIDE MEA, FRAGRANCE (PARFUM), GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM BENZOATE, POLYQUATERNIUM-10, PEG-7M, DMDM HYDANTOIN, TETRASODIUM EDTA, PROPYLENE GLYCOL, BENZYL ALCOHOL, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, CYMBOPOGON SCHOENANTHUS EXTRACT, MINERAL OIL, SODIUM POLYNAPHTHALENESULFONATE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, POTASSIUM SORBATE, BLUE 1 (CI 42090),  RED 33 (CI 17200).

LABEL COPY

INGREDIENTS AND APPEARANCE

FRUITOPIA 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-421
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DIMETHICONE (UNII: 92RU3N3Y1O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CUCUMBER (UNII: YY7C30VXJT)
CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM 2-NAPHTHALENESULFONATE (UNII: R5F0CTD2OJ)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
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: 59779-421-14	400 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/17/2012

Labeler - CVS PHARMACY (062312574)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture