Label: ALDAMED- sundermia sun-exposure skin relief gel gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 16, 2023

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

  • Active ingredient

    Menthol 3%.....................Topical Analgesic

  • PURPOSE

    Topical Analgesic

  • Use

    Temporary relief of pain from sunburn, minor burns, bruises, and scrapes.

  • warnings

    For external use only. 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

    Aqua, glycerin, biosacharide gum-1, polysorbate 80, prunus amygdalus dulcis oil, carbomer, phenoxyethanol, ethylhexylglycerin, panthenol, hippophae rhamnoides fruit extract, rosmarinus officinalis leaf extract, simmondsia chinensis seed oil, calendula officinalis flower extract, menthol 0,3%, beta-glucan, sodium hydroxide, rosa canina fruit oil, aloe barbadensis leaf juice, tocopheryl acetate, persea gratissima oil, hydrogenated palm glycerides, butyrospermum parkii butter, lavandula officinalis flower extract, arnica montana flower extract, hypericum perforatum extract, melissa officinalis flower/leaf/stem extract, camellia sinensis flower extract, centella asiatica extract, vaccinium myrtillus fruit extract, vitis vinifera seed oil, chamomilla recutita flower extract, hamamelis virginiana leaf extract, macadamia ternifolia seed oil, babassu oil glycereth-8 esters, prunus armeniaca kernel oil, D&C orange no 4.

  • PRINCIPAL DISPLAY PANEL

    Sundermia200 mL NDC: 82810-114-11

  • INGREDIENTS AND APPEARANCE
    ALDAMED 
    sundermia sun-exposure skin relief gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82810-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BABASSU OIL GLYCERETH-8 ESTERS (UNII: 12XQ76K0YL)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    BILBERRY (UNII: 9P2U39H18W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82810-114-11200 mL in 1 TUBE; 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(82810-114)