Label: PETROLATUM jelly

  • 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 December 13, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient                            Purpose

    White Petrolatum 100%                 Skin Protectant            

  • Uses:

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

    For external use only.

  • When using this product:

    Do not get in eyes.

  • Stop use and ask a doctor if:

    • Condition worsens
    • symptoms last more than 7 days or clear up and occur in 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:

    • 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 - 30 Deg C (59 Deg F - 86 Deg F)
    • Avoid excessive heat 
  • Indications and Usage

    Skin Protectant

  • Principal Display Panel:

    Petrolatum Jelly

    Petrolatum_Jelly.jpg

  • INGREDIENTS AND APPEARANCE
    PETROLATUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-400-0112 in 1 CASE
    16 in 1 BOX
    1113.4 g in 1 TUBE
    2NDC:67777-400-0212 in 1 CASE
    26 in 1 BOX
    228.35 g in 1 TUBE
    3NDC:67777-400-0312 in 1 CASE
    36 in 1 BOX
    358.7 g in 1 TUBE
    4NDC:67777-400-0412 in 1 CASE
    4425.2 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/23/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic PharmaIndia Private Limited918531450manufacture(67777-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amar Remedies Limited915839811manufacture(67777-400)
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