Label: RESINOL- petrolatum and resorcinol ointment

  • NDC Code(s): 67492-105-11, 67492-105-12, 67492-105-13, 67492-105-14, view more
    67492-105-15
  • Packager: ResiCal, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 16, 2022

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  • Active ingredients

    Petrolatum 55%, Resorcinol 2%

  • Uses

    • temporarily protects minor
      • cuts
      • scrapes
      • burns
    • temporarily relieves pain and itching associated with
      • minor skin irritations
      • minor burns
      • sunburn
      • minor cuts
      • scrapes
      • insect bites
      • rashes due to poison ivy, oak, and sumac
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last 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.

  • Directions

    • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
    • children under 2 years: ask a doctor
  • Inactive ingredients

    calamine, corn starch, lanolin, zinc oxide

  • Questions or comments?

    1-800-204-6434      www.resinol.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: ResiCal, Inc.
    Orchard Park, NY 14127

  • PRINCIPAL DISPLAY PANEL - 85.1 g Jar Label

    Resinol®

    Topical Analgesic/Skin Protectant
    MEDICATED OINTMENT

    For fast soothing relief of
    MINOR SKIN IRRITATIONS

    NET WT 3 OZ (85.1 g)

    PRINCIPAL DISPLAY PANEL - 85.1 g Jar Label
  • INGREDIENTS AND APPEARANCE
    RESINOL 
    petrolatum and resorcinol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67492-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM55 g  in 100 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67492-105-1293.6 g in 1 JAR; Type 0: Not a Combination Product06/29/200212/19/2019
    2NDC:67492-105-1135.4 g in 1 JAR; Type 0: Not a Combination Product06/29/2002
    3NDC:67492-105-1325.5 g in 1 JAR; Type 0: Not a Combination Product06/29/2002
    4NDC:67492-105-1485.1 g in 1 JAR; Type 0: Not a Combination Product06/29/2002
    5NDC:67492-105-1550 g in 1 TUBE; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/29/2002
    Labeler - ResiCal, Inc. (927081369)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurora Labs LLC.176110547MANUFACTURE(67492-105)
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