Label: CLASSIC CLEAN- shampoo shampoo

  • NDC Code(s): 63148-580-14
  • Packager: Apollo Health and Beauty Care
  • 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 May 15, 2023

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  • 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

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

    Keep ot of reach of Children

    Keep ot of reach of Children. In case of accidental ingestion, gety medical help or contact a Poison Control Center immediately.

  • Directions

    • For best results, use at least twice a week or as directed by a Doctor.
    • Wet hair, massage onto scalp and rinse
    • repeat if desired.
  • Inactive Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Fragrance (Parfum), Laureth-4, Polyquaternium-113, Sodium Hydroxide, Zinc Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Questions?

    1-844-344-5071

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    CLASSIC CLEAN 
    shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1000 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    DIRECT BLUE 1 (UNII: 8NN34MAQ6H)  
    ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-580-14400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03204/28/2023
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-580)
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