Label: ALDAMED- painelimin with collagen cooling gel

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

Drug Label Information

Updated November 13, 2023

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

  • Active ingredient

    Menthol 3%.....................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

    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

    water, alcohol denat., glycerin, symphytum officinale root extract, aesculus hippocastanum seed extract, eucalyptus globulus leaf oil, abies alba leaf oil, dimethyl sulfone, equisetum arvense extract, mentha piperita oil, magnesium pca, sodium hyaluronate, thymus vulgaris oil, juniperus communis fruit oil, nelumbo nucifera flower water, nymphaea coerulea flower water, arnica montana flower extract, ginkgo biloba leaf extract, hydrolyzed collagen, scutellaria baicalensis extract, pinus pumila twig leaf oil, pinus mugo twig oil, echinacea purpurea extract, agrimonia eupatoria extract, calendula officinalis flower extract, vaccinium myrtillus fruit extract, polygonum bistorta root extract, citrus limon fruit oil, citrus grandis peel oil, rosmarinus officinalis leaf oil, lavandula angustifolia oil, calluna vulgaris extract, ribes nigrum fruit extract, chamomilla recutita flower extract, carbomer, polysorbate 80, phenoxyethanol, sodium hydroxide, ethylhexylglycerin, peg-12 dimethicone

  • PRINCIPAL DISPLAY PANEL

    PainEllimin200 mL, NDC: 82811-111-11

  • INGREDIENTS AND APPEARANCE
    ALDAMED 
    painelimin with collagen cooling gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82811-111
    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) MENTHOL3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NYMPHAEA CAERULEA FLOWER VOLATILE OIL (UNII: 869334Z0JF)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    AGRIMONIA EUPATORIA (UNII: EBU0U94820)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    PINE NEEDLE OIL (PINUS MUGO) (UNII: 6KF1RLN1CI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ABIES ALBA LEAF OIL (UNII: G49QS877DA)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGONUM BISTORTA ROOT (UNII: X23X6CW68R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    THYME OIL (UNII: 2UK410MY6B)  
    NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  
    BLACK CURRANT (UNII: 9755T40D11)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BILBERRY (UNII: 9P2U39H18W)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    ALCOHOL (UNII: 3K9958V90M)  
    CALLUNA VULGARIS WHOLE (UNII: DTE28NXG2W)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    MAGNESIUM PIDOLATE (UNII: V5PC588N7G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82811-111-11200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/08/2022
    Labeler - Herbamedicus, s.r.o. (495275964)
    Establishment
    NameAddressID/FEIBusiness Operations
    Green Idea s.r.o.361646523manufacture(82811-111)