Label: GENTLE STEPS VITAMINS A AND D DIAPER RASH AND SKIN PROTECTANT- lanolin, petrolatum 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 October 26, 2021

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  • Drug Facts

  • Active ingredients

    Lanolin 15.5%
    Petrolatum 53.4%

  • Purpose

    Diaper rash ointment
    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
    • temporarily protects minor: 
       • cuts  • scrapes  • burns
    • temporarily protects and helps relieve chapped or cracked skin and lips

  • Warnings

    For external use only

    Do not use on
    • deep or puncture wounds 
    • animal bites   • serious burns 

    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

    • for diaper rash use:
       • 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
    • for skin protectant use: apply as needed

  • Other information

    store between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

  • Questions?

    1-888-309-9030

  • SPL UNCLASSIFIED SECTION

    Compare to active ingredients of A+D® Original Ointment*

    • Helps treat and prevent diaper rash

    • Helps seal out wetness

    • Dye free, Paraben free & Phthalate free

    *This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of A+D® Original Ointment.

    DISTRIBUTED BY OLD EAST MAIN CO.
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072
    MADE IN INDIA

    100% Satisfaction Guaranteed!

    If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

    (888) 309-9030

  • Packaging

    OldEast

  • INGREDIENTS AND APPEARANCE
    GENTLE STEPS VITAMINS A AND D DIAPER RASH AND SKIN PROTECTANT 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-805-721 in 1 BOX10/06/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/06/2021
    Labeler - Old East Main CO. (068331990)
    Registrant - Ashtel Studios Inc. (148689180)
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