Label: RITE AID RENEWAL CLINICAL- selenium sulfide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 28, 2013

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  • 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 PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY.

    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

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

  • QUESTIONS OR COMMENTS?

    1-866-695-3030

  • INACTIVE INGREDIENTS:

    WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, ACRYLATES COPOLYMER, AMMONIUM XYLENESULFONATE, 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

  • INGREDIENTS AND APPEARANCE
    RITE AID RENEWAL  CLINICAL
    selenium sulfide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6181
    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)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    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 SODIUM (UNII: MP1J8420LU)  
    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:11822-6181-4420 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/26/2013
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(11822-6181)
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