Label: DAYLOGIC MAXIMUM STRENGTH DANDRUFF- 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 February 10, 2016

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  • Active ingredient

    Selenium Sulfide 1%

    Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Uses

    helps prevent the 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.

    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

    • 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

  • INGREDIENTS AND APPEARANCE
    DAYLOGIC MAXIMUM STRENGTH DANDRUFF 
    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)  
    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:11822-6181-3420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/09/2016
    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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