Label: TEA TREE DAILY CLEANSER 6.4OZ- salicylic acid 2% 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 December 21, 2020

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  • PURPOSE

    Purpose

    Acne treatment

  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid (2.0%)

  • DOSAGE & ADMINISTRATION

    Directions

    Squeeze a nickel size amount onto fingertips and gently massage onto face. Spread in small circular motions, then rinse and glow. For best results, use daily.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betain, Glycerin, Ammonium Chloride, Sodium Lauroyl Sarcosinate, Propylene Glycol, Fragrance, PEG-150 Distearate, Disodium EDTA, Iodopropynyl Butylcarbamate, Menthol, Melalueca Alternnifolia (Tea Tree) Leaf Extract, FD&C Yellow No.5, FD&C Blue No.1.

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • INDICATIONS & USAGE

    Uses

    • For the management of acne
  • OTHER SAFETY INFORMATION

    Other Information

    Store at room temperature

    Questions / Comments?

    1-855-345-5575

  • WHEN USING

    When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TEA TREE DAILY CLEANSER  6.4OZ
    salicylic acid 2% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-161-01189 mL in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/11/2019
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-161)
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