Label: ASTONEA PETROLATUM- petrolatum ointment

  • NDC Code(s): 77338-211-01, 77338-211-02, 77338-211-03, 77338-211-04, view more
    77338-211-05, 77338-211-06, 77338-211-07, 77338-211-08
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 24, 2024

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  • Active Ingredient (in each gram)

    White Petrolatum, USP, 100% w/w

  • Purpose

    Skin Protectant

  • Uses

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

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

    For External Use Only.

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    Stop use and ask a doctor if

    • The condition persists or gets worse
    • Symptoms persists for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Other information

    • Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
    • Avoid excessive heat and humidity
    • Tamper evident
    • Do not use if packet is torn, cut or opened

    When using this product

    • Do not get into eyes
  • Inactive Ingredients

    None

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-211
    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:77338-211-015 g in 1 PACKET; Type 0: Not a Combination Product02/22/2013
    2NDC:77338-211-0256.6 g in 1 TUBE; Type 0: Not a Combination Product02/05/2013
    3NDC:77338-211-03368.5 g in 1 JAR; Type 0: Not a Combination Product02/05/2013
    4NDC:77338-211-04226 g in 1 JAR; Type 0: Not a Combination Product02/01/2023
    5NDC:77338-211-05368 g in 1 JAR; Type 0: Not a Combination Product02/01/2023
    6NDC:77338-211-06425 g in 1 JAR; Type 0: Not a Combination Product02/01/2023
    7NDC:77338-211-07113 g in 1 TUBE; Type 0: Not a Combination Product02/05/2013
    8NDC:77338-211-08100 g in 1 JAR; Type 0: Not a Combination Product02/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/05/2013
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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