Label: JELL WITH VITAMIN A D- lanolin, petrolatum ointment

  • NDC Code(s): 30400-215-01, 30400-215-02, 30400-215-03, 30400-215-04, view more
    30400-215-10, 30400-215-20, 30400-215-30, 30400-215-40
  • Packager: Jell Pharmaceuticals Pvt Ltd.
  • 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 5, 2022

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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 and burns ■ temporarily protects and relieve chapped,chafed or cracked skin or 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: ■ 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 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

  • Inactive ingredients

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

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    JELL  WITH VITAMIN A D
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-215-201 in 1 BOX01/12/2022
    1NDC:30400-215-0256.6 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:30400-215-101 in 1 BOX01/12/2022
    2NDC:30400-215-0128.3 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:30400-215-301 in 1 BOX01/12/2022
    3NDC:30400-215-0385 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:30400-215-401 in 1 BOX01/12/2022
    4NDC:30400-215-04113.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/12/2022
    Labeler - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt Ltd.726025211manufacture(30400-215)
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