Label: CURETECH- white petrolatum ointment

  • 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 8, 2020

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  • Active Ingredient

    White Petroleum Jelly USP [100% w/w]

  • Purpose

    Skin Protectant

  • Uses

    ■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

  • 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 in a few days

  • Do not use on

    ■ deep puncture woulnd ■ 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

  • Directions

    ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

  • Other Information

    ■ store at 59-86F (15-30C) ■ avoid excessive heat

  • Inactive Ingredient

    None

  • Package Label

    Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    CURETECH 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73622-3020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73622-3020-25 g in 1 PACKET; Type 0: Not a Combination Product09/23/2013
    2NDC:73622-3020-357 g in 1 TUBE; Type 0: Not a Combination Product09/23/2013
    3NDC:73622-3020-4113 g in 1 TUBE; Type 0: Not a Combination Product09/23/2013
    4NDC:73622-3020-5425 g in 1 JAR; Type 0: Not a Combination Product09/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/23/2013
    Labeler - Curetech Skincare (677682180)
    Establishment
    NameAddressID/FEIBusiness Operations
    Curetech Skincare677682180manufacture(73622-3020)
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