Label: BABY CARE VITAMINS A AND D- lanolin 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 March 7, 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

    •
    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 any time when exposure to wet diapers may be prolonged
  • Other Information

    store at 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

    baby care
    vitamins
    A&D ointment
    diaper rash ointment

    skin protectant

    NET WT 4 OZ. (113 g)

    SATISFACTION GUARANTEE
    IF YOU’RE NOT SATISFIED, WE’LL HAPPILY REFUND YOUR MONEY.

    DISTRIBUTED BY:
    RITE AID,
    30 HUNTER LANE
    CAMP HILL, PA 17011

    MANUFACTURED IN ISRAEL
    0G327 83 T1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    BABY CARE VITAMINS A AND D 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3271
    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:11822-3271-11 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/05/2014
    Labeler - Rite Aid Corporation (014578892)
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