TOPCARE 2 IN 1 DANDRUFF GREEN APPLE- pyrithione zinc liquid 
TOPCO ASSOCIATES LLC

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

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 LAURETH SULFATE, SODIUM LAURYL SULFATE, DIMETHICONE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)

LABEL COPY

IMAGE OF THE LABEL

TOPCARE  2 IN 1 DANDRUFF GREEN APPLE
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALMOND OIL (UNII: 66YXD4DKO9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-231-14420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/27/2014
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(36800-231)

Revised: 7/2014
Document Id: b27e7eff-8fd5-47e1-bdb8-3ff137ff1e8c
Set id: 040315ce-0bd9-4ad9-85a7-048879ff4381
Version: 1
Effective Time: 20140728
 
TOPCO ASSOCIATES LLC