Label: PAIN RELIEF GEL-ROLL ON- menthol gel

  • NDC Code(s): 83016-331-01, 83016-331-11, 83016-331-21
  • Packager: R & Y Group, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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

  • Active Ingredient

    Menthol 4.0% w/w ...... Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • Uses

    ■ For temporary relief of minor aches and pains of muscles and joints

  • 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 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 irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place

  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

  • If pregnant or breast-feeding

    ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    ■ Adults and children 12 years of age and older:

    Rub a thin film over affected areas not more than 4 times daily; massage not necessary

    ■ Children under 12 years of age: Consult Physician

  • Inactive Ingredients

    Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

  • QUESTIONS

    www.theraice.com

  • PRINCIPAL DISPLAY PANEL

    Bottle label:

    Bottle label

    ---

    Bag (1 bottle) label:

    Bag label

    ---

    Bag (3 bottles) label:

    21

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL-ROLL ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83016-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.04 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL 95% (UNII: 7528N5H79B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83016-331-111 in 1 BAG10/27/2023
    1NDC:83016-331-0174 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83016-331-213 in 1 BAG11/01/2023
    2NDC:83016-331-0174 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/27/2023
    Labeler - R & Y Group, LLC (968585765)
    Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(83016-331)