Label: TENDERPHOR- skin protectant ointment

  • NDC Code(s): 77338-014-23
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • Active Ingredient:

    Petrolatum 44.28%

  • Purpose:

    Skin Protectant

  • Uses:

    • Temporarily protects minor cuts, scrapes, burns.
    • Temporarily protects and helps relieve chapped or cracked skin and lips.
    • Helps protect skin from the drying effects of wind and cold weather.
  • Warnings:

    ​For external use only.

  • Warnings:

    Avoid contact with eyes. In case of contact, flush thoroughly with water.

  • Warnings:

    Stop and ask a doctor if

    • condition worsens
    • ​symptoms last more than 7 days or clear up and occur again within a few days
  • ​Warnings:

    Do not use ​on deep or puncture wounds, animal bites, or serious wounds.

  • ​Warnings:

    Keep out of reach of children.

    ​Incase of accidental ingestion contact a Physician or Poison Control Center right away.

  • Directions:

    Apply liberally to affected area as needed.

  • Other Information:


    ■Store at room temperature 15°-30°C (68°-77°F)

  • Inactive Ingredients:

    Lanolin Alcohol, Light Liquid Paraffin, Microcrystalline Wax, Paraffin

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    TENDERPHOR 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM44.28 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-014-23113 g in 1 TUBE; Type 0: Not a Combination Product08/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/17/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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