Label: PAIN RELIEVING GEL- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient

    Menthol 4%

  • Purpose

    External analgesic

  • Uses

    for temporary relief from minor aches and pains of muscles & joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

  • When using this product

    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Other information

    • store in a cool dry place with lid closed tightly
  • Inactive ingredients

    Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5

  • Disclaimer

    *This product is not manufactured or distributed by Biofreeze Performance Health, distributor of BioFreeze ® Cool the Pain Roll-On Fast Acting Menthol Pain Relief

  • Adverse reaction

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE,

    CAMP HILL, PA 17011

    www.riteaid.com

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient of Biogreeze ® Roll-on*

    ROLL-ON COOLING PAIN RELIEF

    4% MENTHOL

    for arthritis, sore muscles, joints & back pain

    soothing menthol

    diminishing scent

    paraben-free

    2.5 FL OZ (73 mL)

    mm01

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8940
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-8940-174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2023
    Labeler - Rite Aid (014578892)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11822-8940)