A AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]

A AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]
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NDC 67234-030-01
Set ID fcaf27c9-3634-4fb7-a311-2e093f055278
Category HUMAN OTC DRUG LABEL
Packager Natureplex LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Lanolin 15.5% Skin protectant
    Petrolatum 53.4% Skin protectant
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  • 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
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  • 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.

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  • 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
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  • 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.
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  • Inactive ingredients

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

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  • Questions or comments?

    866-323-0107 or www.natureplex.com

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  • 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
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  • INGREDIENTS AND APPEARANCE
    A AND D   DIAPER RASH AND SKIN PROTECTANT
    lanolin and petrolatum cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-030
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin 0.15 mg  in 1 g
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum 0.53 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL (UNII: T5L8T28FGP)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67234-030-01 1 in 1 BOX 11/12/2014
    1 42.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 11/12/2014
    Labeler - Natureplex LLC (062808196)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex LLC 062808196 MANUFACTURE(67234-030)
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