Label: PCA SKIN SKIN PROCEDURE- petrolatum ointment

  • NDC Code(s): 68726-680-01
  • Packager: CP Skin Health Group, Inc.
  • 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 30, 2023

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  • Drug Facts

  • Active ingredient

    Petrolatum 60%

    Purpose

    Skin protectant (ointment)

  • Uses

    • temporarily protects minor: º cuts º scrapes º burns • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin • helps prevent and protect skin from the drying effects of wind and cold weather 

  • 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 within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites 
    • serious burns

    Do not use on damaged and broken skin

    Keep out of reach of children

  • Directions

    • Apply as needed or as directed by physician 
    • for best results, apply liberally to moist skin.
  • Other information

    • Do not use if package is broken or open 
    • protect this product from excessive heat and direct sun
    • noncomedogenic 
    • fragrance-free
    • hypoallergenic
  • Inactive ingredients

    Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tincotirius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosamarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycyrrhetinate, Tocopherol, Tocopheryl Acetate.

  • Questions?

    Please call 877.722.7546

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    PCA SKIN SKIN PROCEDURE 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-680
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM600 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    RICE BRAN (UNII: R60QEP13IC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSEMARY (UNII: IJ67X351P9)  
    MILK THISTLE (UNII: U946SH95EE)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68726-680-0162.1 mL in 1 TUBE; Type 0: Not a Combination Product09/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/10/2019
    Labeler - CP Skin Health Group, Inc. (611921669)
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