Label: GZE SALICYLIC ACID CREAM- salicylic acid cream

  • NDC Code(s): 83566-164-01
  • Packager: Guangzhou Yilong Cosmetics Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 7, 2024

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  • Active ingredients

    Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

    Cocos Nucifera (Coconut) Oil 3%

    Salicylic Acid 2%

    Aloe Barbadensis Leaf Juice 1%

    Camellia Sinensis Leaf Extract 1%

  • Purpose.

    GZE salicylic acid cream is help to exfoliate, benifit to moisture.

  • Uses

    Apply to affected area twice per day on cleansed skin.Use continuously for 2-3 weeks for bestre sults.After then, apply as needed to maintain healthy, beautiful skin.

  • WARNINGS

    For external use only.

  • Stop use and ask a doctor if

    rash occurs.

  • Do not use

    on damaged or broken skin.

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION


    Apply to affected area twice per day on cleansed skin. Use
    continuously for 2-3 weeks for best results. There after, apply as needed to
    maintain healthy, beautiful skin.

  • INACTIVE INGREDIENT

    GLYCERIN
    PHENOXYETHANOL

    MINERAL OIL

    CARBOMER 980

    PEG-100 STEARATE

    ALLANTOIN

    WATER
    POLYSORBATE 60

    GLYCERYL STEARATE SE
    HEXYLENE GLYCOL
    DODECANE
    CAPRYLYL GLYCOL

    ETHYLHEXYLGLYCERIN

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GZE SALICYLIC ACID CREAM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L) COCONUT OIL3 mg  in 100 g
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G) (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL - UNII:VIF565UC2G) MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL5 mg  in 100 g
    ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ) (ALOE ANDONGENSIS LEAF - UNII:N1P4NU25EJ) ALOE ANDONGENSIS LEAF1 mg  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 g
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) (CAMELLIA SINENSIS FLOWER - UNII:9I2BJY2J17) CAMELLIA SINENSIS FLOWER1 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DODECANE (UNII: 11A386X1QH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-164-01100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/20/2023
    Labeler - Guangzhou Yilong Cosmetics Co.,Ltd. (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yilong Cosmetics Co.,Ltd.712647107manufacture(83566-164)
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