Label: PRIYAL COLD ICE ANALGESIC GEL- menthol gel

  • 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 July 22, 2020

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  • Active Ingredient

    Menthol 2.0%

  • Purpose

    Topical Analgesic

  • Uses:

    • for temporary relief of minor aches and pains in muscles and joints associated with:
    • simple backaches,
    • strains
    • sprains
    • sports injuries
    • arthritis
    • bruises
  • Warnings

    FOR EXTERNAL USE ONLY

    Do not use:

    • with other topical pain relievers
    • with heating pads or heating devices

  • When using this product

    • do not use in or near eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • 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
    • redness or irritation develops
  • If pregnant or breastfeeding

    ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get Medical Help or contact a Poison Control Center right away

  • Directions

    • clean affected area before applying product
    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • Inactive Ingredients

    ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

  • PRINCIPAL DISPLAY PANEL

    Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    PRIYAL COLD ICE ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72822-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.54 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    THYMOL (UNII: 3J50XA376E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72822-303-12227 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/08/2019
    Labeler - Priyal Cosmetics (675482356)
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