Label: DRAGON PAIN RELIEF- menthol, unspecified form gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 4%

  • Purpose

    Topical analgesic

  • Uses

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

    For external use only

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

    When using this product

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

    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

    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 (1-800-222-1222) right away.

  • 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
  • Other information

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

  • Questions or comments?

    Call toll free 1-877-994-3666
    Monday to Friday, 8 am to 6 pm Central time.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Genomma Lab USA, Inc., Houston, TX 77027

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    MEDICINAL SCENT

    GEL
    DRAGON®

    WITH ARNICA

    PAIN RELIEF GEL

    Menthol 4% topical pain reliever

    INFUSED WITH
    ARNICA

    Non-greasy gel formula

    Relieves muscle, back and joint pain,
    bruises, strains and sprains.

    COOLING EFFECT

    Fast Acting

    NET. WT 2.0 oz (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN RELIEF 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-410-021 in 1 CARTON11/12/2020
    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 NOT FINALpart34811/12/2020
    Labeler - Genomma Lab USA (832323534)
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