Label: GZE NIPPLE BALM (butyrospermum parkii- shea butter paste

  • NDC Code(s): 83566-048-01
  • Packager: Guangzhou Yilong Cosmetics Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 18, 2024

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  • ACTIVE INGREDIENT

    BUTYROSPERMUM PARKII (SHEA) BUTTER

    COCOS NUCIFERA (COCONUT) OIL

    OLEA EUROPAEA (OLIVE) FRUIT OIL

  • INACTIVE INGREDIENT

    BEESWAX

    TOCOPHEROL

    BISABOLOL

    AROMA

  • PURPOSE

    Moisturising.

  • INDICATIONS & USAGE

    Use anytime on sore, cracked nursing nipples to soften and smooth the skin.
    It can also be used to moisturize lips, heels, elbows and other areas.

  • WARNINGS

    For external use only.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • 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.

  • DOSAGE & ADMINISTRATION

    Take a coin-sized amount of cream, apply to desired area and massage until absorbed.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GZE NIPPLE BALM 
    butyrospermum parkii (shea butter) paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER58.73 g  in 100 g
    COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L) COCONUT OIL12.36 g  in 100 g
    OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E) OLIVE OIL8.46 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    AROMADENDRIN (UNII: 7YA4640575)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-048-0160 g in 1 JAR; Type 0: Not a Combination Product06/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/23/2023
    Labeler - Guangzhou Yilong Cosmetics Co., Ltd (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yilong Cosmetics Co., Ltd712647107manufacture(83566-048)
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