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
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • 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 January 12, 2023

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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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/05/2013
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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