Label: ALDAMED- painelimin extra strong cooling gel

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

Drug Label Information

Updated November 14, 2023

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

  • Active ingredient

    Menthol 2%.....................Topical Analgesic

    Camphor 3%. .................Topical Analgesic

  • PURPOSE

    Topical Analgesic

  • Use

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, simple backache, bruises, strains, and sprains.

  • warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    directly on mucous membranes

    on open skin wounds or burns

  • When using this product

    do not use it in or near the eyes or mouth.

  • ASK DOCTOR

    if pregnant or if you have a cough associated with smoking, excessive phlegm, asthma, emphysema, or persistent or chronic cough.

  • Stop use and ask a doctor

    if irritation, itching, or rash occurs.

  • Keep out of reach of children

    If swallowed, get medical help, or contact a poison control center immediately at 1-800-222-1222.

  • Directions

    apply on the affected area and rub gently till absorbed. Apply up to 3 times daily.

    do no use on children below the age of 3 years old

  • Other information

    Store in a cool, and dry place and avoid freezing and excessive heat

    Do not expose the product to the direct sunlight

  • Inactive ingredient

    abies alba leaf oil, aesculus hippocastanum seed extract, agrimonia eupatoria extract, alcohol denat., arnica montana flower extract, calendula officinalis flower extract, calluna vulgaris extract, carbomer, chamomilla recutita (matricaria) flower extract, citrus grandis (grapefruit) peel oil,, citrus limon fruit oil, d&c green no.6, echinacea purpurea extract, ethylhexylglycerin, eucalyptus globulus leaf oil, ginkgo biloba leaf extract, glycerin, juniperus communis fruit oil, lavandula angustifolia oil, mentha piperita oil, peg-12 dimethicone, phenoxyethanol, pinus mugo twig oil, pinus pumila twig leaf oil, polysorbate 80, ribes nigrum fruit extract, rosmarinus officinalis leaf oil, scutellaria baicalensis extract, sodium hydroxide, symphytum officinale root extract, thymus vulgaris oil, vaccinium myrtillus fruit extract, water

  • PRINCIPAL DISPLAY PANEL

    Extra Strong500 mL NDC: 82810-112-11

  • INGREDIENTS AND APPEARANCE
    ALDAMED 
    painelimin extra strong cooling gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82810-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 mg  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    AGRIMONIA EUPATORIA (UNII: EBU0U94820)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BLACK CURRANT (UNII: 9755T40D11)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALLUNA VULGARIS WHOLE (UNII: DTE28NXG2W)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PINE NEEDLE OIL (PINUS MUGO) (UNII: 6KF1RLN1CI)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BISTORTA OFFICINALIS ROOT (UNII: X23X6CW68R)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    THYME OIL (UNII: 2UK410MY6B)  
    BILBERRY (UNII: 9P2U39H18W)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GINKGO (UNII: 19FUJ2C58T)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    ABIES ALBA LEAF OIL (UNII: G49QS877DA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82810-112-11500 mL in 1 CONTAINER; Type 0: Not a Combination Product09/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/06/2022
    Labeler - Green Idea s.r.o. (361646523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Green Idea s.r.o.361646523manufacture(82810-112)