Label: NATURALS BY SAFETY 1ST- zinc oxide ointment

  • 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 9, 2012

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  • Active ingredient

    Zinc Oxide 10%

  • Purpose

    Skin Protectant

  • Uses

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

    For external use only.

    When using this product

    • Do not get into eyes.
  • 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
  • Keep out of reach of children

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

  • 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
  • Other information

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

  • 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

  • INGREDIENTS AND APPEARANCE
    NATURALS BY SAFETY 1ST 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50428-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.8 g  in 88 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50428-3001-86 in 1 CARTON
    1NDC:50428-3001-788 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2010
    Labeler - Dorel Juvenile Group (118841501)
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