Label: A D AND L ORIGINAL DIAPER RASH SKIN- lanolin, petrolatum ointment

  • 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 September 12, 2014

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  • Active ingredient

    Lanolin, 15.5%
    Petrolatum, 53.4%

  • Purpose

    Diaper Rash Ointment
    Skin protectant

  • Uses

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

  • Directions

    •
    for skin protectant use: 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 anytime when exposure to wet diapers may be prolonged
  • Other information

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

  • Inactive ingredients

    cod liver oil, fragrance, light mineral oil, microcrystalline wax, paraffin.

  • Package/Label Principal Display Panel

    buybuyBABYTM

    diaper rash
    ointment &
    skin protectant

    Rich in
    Vitamins
    A&D

    Helps Treat & Prevent Diaper Rash
    Forms a Protective Barrier on Skin
    to Help Seal Out Wetness

    NET WT 16 OZ (454 g)

    MADE EXPRESSLY FOR
    buybuyBABY™
    650 LIBERTY AVENUE,
    UNION, NJ 07083
    ©BUY BUY BABY INC.
    WWW.BUYBUYBABY.COM

    MADE IN ISRAEL
    0G343 B1 B1

    Peel for
    Full Labeling

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    A D AND L ORIGINAL DIAPER RASH SKIN 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-343
    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)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-343-12454 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2014
    Labeler - Harmon Stores Inc. (804085293)
    Registrant - Emilia Cosmetics Ltd (600076624)
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