Label: SKIN-LUBE- alcohol ointment

  • NDC Code(s): 59316-995-21, 59316-995-95, 59316-995-96, 59316-995-97
  • Packager: Performance Health, LLC
  • Category: HUMAN OTC DRUG LABEL

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 August 7, 2022

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  • Drug Facts

  • Active Ingredients

    ​Petrolatum 85%

    Dimethicone 1.5%

    Purpose

    ​Skin Protectant

  • Uses

    Temporarily protects minor - cuts  - scrapes  - burns  -- Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin.  Helps prevent and protect from the drying effects of wind and cold weather.

  • 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.

    Stop use and ask a doctor if

    - condition worsens  - symptoms last more than 7 days or clear up and occur again within few days.

  • Directions:

    Apply as needed.

    Keep out of reach of children.

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

  • Other Information:

    Store in a cool dry place with lid closed tightly

  • Inactive Ingredients

    Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate

  • Questions?

    (800) 345-2231

  • Package Labeling: 59316-995-95

    Label11

  • INGREDIENTS AND APPEARANCE
    SKIN-LUBE 
    alcohol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM850 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-995-2178 g in 1 JAR; Type 0: Not a Combination Product05/18/201712/31/2024
    2NDC:59316-995-9511340 g in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
    3NDC:59316-995-96454 g in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
    4NDC:59316-995-972270 g in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/18/201712/31/2024
    Labeler - Performance Health, LLC (794324061)
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