Label: CRASH CREAM- white petrolatum ointment

  • NDC Code(s): 61387-251-01, 61387-251-02
  • Packager: Claridei Laboratories
  • 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 July 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP (50%)

  • PURPOSE

    Purpose

    Skin Protectant

    Uses

    • temporarily protects minor: cuts, scrapes, burns
    • helps relieve, prevent and temporarily protect chaged, chapped or cracked skin
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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
  • WARNINGS

    Warnings

    When using this product do not get into eyes

    Do not use on

    • deep or punctured wounds
    • animal bites
    • serious burns
  • DOSAGE & ADMINISTRATION

    Directions

    • for cuts, scrapes, and bums
    • Clean affected area with soap and water
    • apply frequently enoughto infected areas to prevent a scab from forming
  • INACTIVE INGREDIENT

    Inactive ingredients

    Caprylic/Capric Triglyceride, Coco-Caprylate, Hydrogenated Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Isostearate, C10-30 Cholersterol/Lanosterol Esters, Glycyrhetinic Acid, Phytosphingosine, Ceramide NP, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Crash Cream Ointment

    No Sting

    Advanced Skin Protection

    Net Wt 1.7oz (50g)

    Crash Cream

  • INGREDIENTS AND APPEARANCE
    CRASH CREAM 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61387-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CANDELILLA WAX (UNII: WL0328HX19)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    ENOXOLONE (UNII: P540XA09DR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    CERAMIDE NP (UNII: 4370DF050B)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61387-251-0150 g in 1 TUBE; Type 0: Not a Combination Product07/28/2023
    2NDC:61387-251-0215 g in 1 TUBE; Type 0: Not a Combination Product07/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01607/28/2023
    Labeler - Claridei Laboratories (035627639)
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