Label: DRAGON WITH ARNICAL PAIN RELIEF- menthol gel

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

Drug Label Information

Updated January 2, 2024

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Menthol 4%.......................................................Topical analgesic

  • PURPOSE

    Uses

    • temporarily relieves the minor aches and pains of muscles and joints associated with:
    • sprains
    • simple backache
    • arthirtis
    • strains bruises
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
    • with other ointments, creams, sprays or liniments
  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • use only as directed
    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
    • wash hands after use with cool water
  • STORAGE AND HANDLING

    Other information

    store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Leaf, Arnica Montana Flower, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Isopropyl Alcohol, Methylparaben, Polysorbate 80, Potassium sorbate, Purified water, Tocopheryl Acetate, Trolamine

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Genomma Lab USA, Inc.

    Houston, TX 77027

    Made in China

  • PRINCIPAL DISPLAY PANEL

    5621

  • INGREDIENTS AND APPEARANCE
    DRAGON WITH ARNICAL PAIN RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-621-561 in 1 CARTON11/23/2020
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/23/2020
    Labeler - Genomma Lab USA Inc. (832323534)