Label: VITAMINS A AND D RASH- lanolin and 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 August 14, 2019

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  • Active ingredients

    Lanolin 15.5%

    Petrolatum 53.4%

    Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • temporarily protects minor: cuts, scrapes, burns
    • temporarily protects and relieves chapped, chafed or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. If contact occurs, rinse with water.

    Stop using this product and ask doctor if

    • condition worsens
    • symptoms last for 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.
    • In case of accidental ingestions, get medical help or contact a Poison Control Center immediately.
  • Directions

    • for skin protectant use and apply as needed
    • for diaper rash use: change wet and soiled diapers promptly. Clean the diaper area, and allow to dry. Apply ointment as often as required, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Inactive ingredients

    Cod Liver Oil, Fragrance (Parfum), Mineral Oil, Microcrystalline Wax, Paraffin.

  • Questions/Comments

    1-866-695-3030

  • Other information

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

  • Label Copy

    Image of the description

  • INGREDIENTS AND APPEARANCE
    VITAMINS A AND D RASH 
    lanolin and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3402
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3402-1454 g in 1 JAR; Type 0: Not a Combination Product08/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/13/2019
    Labeler - Rite Aid (014578892)
    Registrant - Apollo Health and Beauty Care Inc. (201902109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(11822-3402)
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