Label: DRAGON PAIN RELIEF (menthol, unspecified form, camphor,- --, and methyl salicylate cream

  • 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 August 16, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Camphor 4%, Menthol 10%, Methyl salicylate 30%

  • Purpose

    Topical analgesics

  • Uses

    Temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Allergy alert

    • If prone to allergic reaction from aspirin or salicylates, consult a doctor before 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

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

    When using this product

    • do not use otherwise than as directed
    • avoid contact with eyes or mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • redness is present or irritation or rash develops
    • conditions worsen or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    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 immediately (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

  • Other information

    • Store between 20° and 25° C (68° and 77° F)
  • Inactive ingredients

    ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

  • Questions or comments?

    Call toll free 1 877 994 3666.

    Monday to Friday 8:00 am – 6:00 pm CST

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    POMADA
    DRAGON®
    ULTRA STRENGTH

    PAIN RELIEF CREAM

    FAST RELIEF OF MUSCLE,
    BACK AND JOINT PAIN

    Deep Penetrating
    Fast Acting Relief

    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, camphor, (-)-, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-40 mg  in 1 g
    methyl salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) methyl salicylate300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    glyceryl monostearate (UNII: 230OU9XXE4)  
    Water (UNII: 059QF0KO0R)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    sorbitan monooleate (UNII: 06XEA2VD56)  
    stearic acid (UNII: 4ELV7Z65AP)  
    ethylparaben (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-412-021 in 1 CARTON08/13/2021
    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 finalpart34808/13/2021
    Labeler - Genomma Lab USA (832323534)
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