Label: TRUEZYME BABY FACE AND BODY- glycerin lotion

  • Category: HUMAN OTC DRUG LABEL

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 November 14, 2016

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  • Active ingredient

    Glycerin

  • Purpose

    Skin protectant

  • DOSAGE & ADMINISTRATION

    For external use only

  • INDICATIONS & USAGE

    • Apply to baby's face and body evenly after a bath or washing.

    • Apply to dry, rough-textured area repeatedly.

    • Use with Truezyme Baby Shampoo & Body Wash for better results.

  • Inactive ingredients:

    Sea Water, Caprylic/Capric Triglyceride, Propanediol, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, etc.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

    1) If there are red spots, swelling, itchiness, or irritation

    2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

    2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

    3. If it gets into eye, wash the eye with clean water immediately.

    4. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity.

    5. Precautions on storage and handling

    1) Make sure to close the cap after use.

    2) Keep out of the reach of children.

    3) Do not keep the product in a hot or cold place or a place getting direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    TRUEZYME BABY FACE AND BODY 
    glycerin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71076-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.008 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71076-0001-1200 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34710/01/2016
    Labeler - Truezyme Co., Ltd. (693938262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Truezyme Co., Ltd.693938262manufacture(71076-0001)
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