Label: A AND D DIAPER RASH AND SKIN PROTECTANT- lanolin and petrolatum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 1, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Lanolin 15.5%Skin protectant
    Petrolatum 53.4%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 chapped or cracked skin and lips
  • 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

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • For skin protectant: apply as needed
    • 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 any time when exposure to wet diapers may be prolonged
  • Other information

    • Store at 15 to 30°C (59 to 86°F).
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    beeswax, cod liver oil (contains vitamin A and vitamin D), fragrance, microcrystalline wax, mineral oil

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

    Natureplex™

    A+D
    OINTMENT

    * Compare active ingredients
    to A&D Original Ointment®

    Use at
    every
    diaper
    change

    NET WT. 1.5 Oz.(42.5g)

    PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box
  • INGREDIENTS AND APPEARANCE
    A AND D   DIAPER RASH AND SKIN PROTECTANT
    lanolin and petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin0.15 mg  in 1 g
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum0.53 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-030-011 in 1 BOX11/12/2014
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/12/2014
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-030)
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