Label: COOL AND EASY RAZOR BUMP PREVENTION- witch hazel solution

  • 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 June 28, 2018

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  • ACTIVE INGREDIENT

    Witch Hazel

  • INACTIVE INGREDIENT

    aluminum alum, citric acid, deionized water , vegetable glycerin.

  • INDICATIONS & USAGE

    Cool & Easy Razor Bump Prevention stops razor bumps and prevent skin irritation from shaving.

  • PURPOSE

    The purpose of the Cool & Easy is to stop razor bumps pseudofolliculitis barbae from shaving. It also stops skin irritation and bleeding of the skin from shaving.

  • DOSAGE & ADMINISTRATION

    The amount used is approximately 2 ml applied tto skin with a cotton swab or cotton applicator. This should be repeated until the entire shaving area has be covered.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children because Cool & Easy is to be used topically only.

  • WARNINGS

    Product is to be used externally only.

  • PRINCIPAL DISPLAY PANEL

    Cool & Easy

  • INGREDIENTS AND APPEARANCE
    COOL AND EASY RAZOR BUMP PREVENTION 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72486-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM ALUM ANHYDROUS (UNII: DPU64XYB1D)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72486-101-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/13/2018
    Labeler - Casanova P. Jackson (883065534)
    Registrant - Casanova P. Jackson (883065534)
    Establishment
    NameAddressID/FEIBusiness Operations
    CPJ Products883065534manufacture(72486-101)
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