Label: VITAMIN A AND D- lanolin and petrolatum ointment

  • NDC Code(s): 55319-103-01
  • Packager: Family Dollar Services Inc
  • 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 November 8, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients

    Lanolin         15.5%

    Petrolatum   53.4%

  • PURPOSE

    Purpose

    Diaper Rash Ointment

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    Helps prevent diaper rash. Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped, chafed or cracked skin. Helps protect chafed skin due to diaper rash and helps seal out wetness.

  • WARNINGS

    Warnings

    For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask doctor if condition worsens or symptoms last more than 7 days. If swallowed, get medical help or contact a poison control center immediately.

    Do not use on deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Direction

    Apply as needed to dry or irritated skin. If using for diaper changes, gently clean diaper area and allow to dry. Apply cream liberally with each diaper change and as often as desired.

  • STORAGE AND HANDLING

    Other Information

    Store at 20°C to 25°C (68°F to 77°F). Do not use if seal under cap on tube is broken, missing or if tube tip is cut prior to opening. Store upright when not in use.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cod liver oil (contains vitamin A&D), fragrance, light mineral oil, microcrystalline wax, paraffin

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    lanolin and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-103
    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:55319-103-01113 g in 1 TUBE; Type 0: Not a Combination Product11/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/08/2017
    Labeler - Family Dollar Services Inc (024472631)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(55319-103)
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