TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH- selenium sulfide 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

SELENIUM SULFIDE 1%

PURPOSE

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

USES

HELPS PREVENT THE CHANCE OF RECURRENCE OF FLAKING, ITCHING, IRRITATION, SCALING AND REDNESS ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS

WARNINGS

FOR EXTERNAL USE ONLY

ASK A DOCTOR BEFORE USING 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

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

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

INACTIVE INGREDIENTS

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, AMMONIUM XYLENESULFONATE, ACRYLATES COPOLYMER, SODIUM HYDROXIDE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700)

LABEL COPY

IMAGE OF THE LABEL

TOPCARE  GENTLE DANDRUFF CLINICAL STRENGTH
selenium sulfide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-618
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-618-14420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/28/2014
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(36800-618)

Revised: 7/2014
Document Id: 518763f2-eeb4-48e9-b869-bedc4645a175
Set id: 1004a6cb-2fbe-4822-800a-4f7296a82ed2
Version: 1
Effective Time: 20140729
 
TOPCO ASSOCIATES LLC