Label: JELL PHARMACEUTICALS VITAMIN A D- petrolatum ointment

  • NDC Code(s): 30400-214-01, 30400-214-02, 30400-214-03, 30400-214-04
  • 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 July 28, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                               Purpose

    White Petrolatum USP (76%)            Skin Protectant

  • Purpose:

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor * cuts * scrapes * burns
    • Temporarily helps protect and help relieve chapped and cracked skin and lips
    • Helps prevent and protect from the drying effects of wind and cold weather
    • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
    • With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
  • Warnings:

    For External Use Only

  • When using this product:

    • Do not get in eyes
  • Dosage & Administration

    Stop use and ask a doctor if:

    • If condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
  • Do not use:

    Do not use:

    • Deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Indications & Usage

    Directions for diaper rash:

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply as needed
  • Other information:

    • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
    • Avoid excessive heat
  • Inactive Ingredients:

    Inactive Ingredients: Light Liquid Parafin, Vitamin A, Vitamin D

  • Principal Display Panel

    Jell Vit AD.jpg

    Jell Vit AD

  • INGREDIENTS AND APPEARANCE
    JELL PHARMACEUTICALS VITAMIN A D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.76 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30400-214-01113.4 g in 1 TUBE; Type 0: Not a Combination Product07/01/2020
    2NDC:30400-214-02425.25 g in 1 JAR; Type 0: Not a Combination Product07/01/2020
    3NDC:30400-214-0328.35 g in 1 TUBE; Type 0: Not a Combination Product07/01/2020
    4NDC:30400-214-0456.7 g in 1 TUBE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/24/2014
    Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Registrant - jell pharmaceuticals pvt.ltd (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(30400-214)