Label: COLD ZONE PAIN RELIEVING GEL- RITE AID- 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 October 5, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients


    Menthol USP 4%

  • Purpose

    Cooling Pain Relief

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains

  • Warnings:

    For external use only

  • Flammable:

    Keep away from excessive heat or open flame.

  • Ask a doctor before use if you have:

    sensitive skin

  • When using this product:


    • Avoid contact with the eyes or mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not use with other ointments, creams, sprays or liniments
    • Do not apply to irritated skin or if excessive irritated develops
    • Do not bandage
    • Wash hands after use with cool water
    • Do not use with heating pad or device
  • Stop use and ask a doctor if:

    Condition worsens, or if symptoms  persist for more than 7 days, or clear up and recur

  • If pregnant or breast-feeding:

    Ask a health professional before use

  • Keep out of reach of children:

    If accidentally ingested, get medical help or contact a Poison Control Center immediately

  • Directions:


    • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
    • Children under 2 years of age: Consult physician
  • Other Information:

    Store in a cool dry place with lid closed tightly.

    Questions or Comments - Call 1-855-314-1850

  • Inactive Ingredients

    Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, camphorm934, colloidal silicon dioxide, FD&C blue no. 1, FD&C yellow no. 5, glycerin,  Iiex paraguariensis leaf extract, Isopropyl alchohol, Isopropyl myristate, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Sorbic acid.

  • Cold Zone Pain Relieving Gel- Rite Aid

    ra pain gel menthol

    1

  • INGREDIENTS AND APPEARANCE
    COLD ZONE PAIN RELIEVING GEL- RITE AID 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    BRILLIANT BLUE G (UNII: M1ZRX790SI)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-314-4888.72 mL in 1 BOTTLE; Type 0: Not a Combination Product01/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/22/2018
    Labeler - Velocity Pharma LLC (962198409)