FRUITOPIA - pyrithione zinc liquid 
CVS PHARMACY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

IMAGE OF THE LABEL

FRUITOPIA 
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-421-14400 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/17/2012
Labeler - CVS PHARMACY (062312574)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 2/2012
Document Id: 1347ce59-5b40-4176-b104-03730d063342
Set id: 39c643ed-ee24-498e-b66f-6c9c42038f07
Version: 1
Effective Time: 20120217
 
CVS PHARMACY