SWEET CHEEKS (ZINC OXIDE) OINTMENT [SAJE NATURAL BUSINESS INC.]

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SWEET CHEEKS (ZINC OXIDE) OINTMENT [SAJE NATURAL BUSINESS INC.]
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Set ID 5fc6486e-8604-5c7b-e053-2991aa0a8d14
Category HUMAN OTC DRUG LABEL
Packager Saje Natural Business Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient

    Zinc Oxide 12%

  • Purpose

    Skin protectant

  • Uses

    helps treat and prevent diaper rash. protects chafed skin or minor skin irritations due to diaper rash. seals out wetness.

  • Warnings

    Warnings

    -Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days.

    Warnings

    -Do not use if allergic to plants of the marshmallow or asteraceae/compositae/daisy family.

    Warnings

    -When using this product, avoid contact with the eyes and mucous membranes.

    Warnings

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

  • Directions

    -Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

    -Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • Other information

    -Store at room temperature.

  • Inactive ingredients

    Olive oil, beeswax (yellow), butyrospermum parkii (shea) butter, coconut oil, castor oil, aloe barbadensis leaf extract, glycerin, vitamin e, calendula officinalis flower extract, hypericum perforatum flower extract (st john's wort), sunflower oil, rosmarinus officinalis (rosemary) leaf extract, echinacea angustifolia extract, camellia sinensis leaf extract (green tea), althaea officinalis root (marshmallow root), daucus carota sativa (carrot) seed oil, lavender oil

  • Questions?

    1-877-275-7253

  • Principal display panel information

    daily diaper rash ointment
    net wt. 75g (2.7 oz) and net wt. 30g (1oz)
    daily diaper rash ointment

  • Sweet cheeks daily diaper rash ointment-Outer label

    Sweet Cheeks 1oz drug factsSweet cheeks box 75g

  • INGREDIENTS AND APPEARANCE
    SWEET CHEEKS 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 75 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ROSEMARY (UNII: IJ67X351P9)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-021-011 in 1 BOX02/15/2018
    175 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:70983-021-0230 g in 1 JAR; Type 0: Not a Combination Product02/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/15/2018
    Labeler - Saje Natural Business Inc. (203413380)
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