Label: PREQUEL- multi purpose skin protectant ointment

  • NDC Code(s): 82800-008-01
  • Packager: The Center Brands, LLC
  • 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 September 21, 2023

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  • Purpose

    Skin Protectant

  • Active Ingredients

    Petrolatum 45.00%

  • Uses

    •Temporarily protects and helps releive chafed, chapped or craked skin and lips

    •Temporarily protects minor:

       •cuts

       •scrapes

       •burns

    •Helps protect form the drying effects of wind and cold weather

  • Warnings

    Fox 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 woulds • animal bites • serious burns.
  • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Inactive Ingredients

    Parrafinum Liquidum, Ozokerite, Dimethicone, Brassica Campestric/Aleuites Fordi Oil Copolymer, Bisabolol, Cetylhydroxyproline Palmitamide, Oryza Sativa Bran Extract, Helianthus Annuus Extract, Tocopherol, Rosmarinus Officinalis Leaf Extract, Stearic Acid, Brassica Campestris Sterols, 1,2-Hexanediol, Hexyldecanol

  • Other Information

    Visit prequelskin.com

  • Principal Display Panel

    82800-008

  • INGREDIENTS AND APPEARANCE
    PREQUEL 
    multi purpose skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM45 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    CERESIN (UNII: Q1LS2UJO3A)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    ROSEMARY (UNII: IJ67X351P9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    RICE BRAN (UNII: R60QEP13IC)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82800-008-011 in 1 BOX07/13/2023
    156.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01607/13/2023
    Labeler - The Center Brands, LLC (076228814)
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