Label: NATURALS BY SAFETY 1ST- zinc oxide ointment

  • NDC Code(s): 50428-3001-7, 50428-3001-8
  • Packager: Dorel Juvenile Group
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active ingredient

    Zinc Oxide 10%

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  • Purpose

    Skin Protectant

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  • Uses

    • Helps improve the skin condition where diaper rash or redness is present.
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  • Warnings:

    For external use only.

    When using this product

    • Do not get into eyes.
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  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
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  • Keep out of reach of children

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

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  • Directions

    • remove safety seal, do not use if broken
    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
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  • Other information

    • store at 59° to 86° F (15° to 30° C)
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  • Inactive ingredients

    Water (Aqua), Canola Oil, Ricinus Communis (Castor) Seed Oil, Stearic Acid, Glycerin, Cetyl Alcohol, Beeswax, Cetearyl Glucoside, Benzyl Alcohol, Sodium Hydroxide, Lonicera Caprifoilum (Honeysuckle) Flower Extract, Lonicera Japanica (Honeysuckle) Flower Extract, Fragrance.

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  • Principal Display Panel

    naturals™ by Safety 1st® Diaper Rash Cream

    Pediatrician tested · Naturally mild & effective

    Developed with safety in mind

    99.09% Natural

    Bath time experts at Safety 1st worked with parents to develop a natural baby bath & body care line that you can count on to be Safety 1st safe & naturally effective.

    • No parabens, phthalates, formaldehyde or dyes
    • No harmful chemicals/preservatives

    Manufactured for Dorel Juvenile Group.

    ©2010 Dorel Juvenile Group. All Rights Reserved.

    2525 State Street, Columbus, IN 47201

    www.djgusa.com (877)657-9545

    www.safety1st.com/babycare

    Made in CANADA

    Principal Display Panel - Tube

    Tube Label

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  • INGREDIENTS AND APPEARANCE
    NATURALS BY SAFETY 1ST 
    zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50428-3001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 8.8 g  in 88 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CANOLA OIL  
    CASTOR OIL  
    STEARIC ACID  
    GLYCERIN  
    CETYL ALCOHOL  
    YELLOW WAX  
    CETEARYL GLUCOSIDE  
    BENZYL ALCOHOL  
    SODIUM HYDROXIDE  
    LONICERA CAPRIFOLIUM FLOWER  
    LONICERA JAPONICA FLOWER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50428-3001-8 6 in 1 CARTON
    1 NDC:50428-3001-7 88 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/01/2010
    Labeler - Dorel Juvenile Group (118841501)
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