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

Dragon Pain Relief by

Drug Labeling and Warnings

Dragon Pain Relief by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 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 salicylate	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
glyceryl monostearate (UNII: 230OU9XXE4)
Water (UNII: 059QF0KO0R)
Polysorbate 80 (UNII: 6OZP39ZG8H)
sorbitan monooleate (UNII: 06XEA2VD56)
stearic acid (UNII: 4ELV7Z65AP)
ethylparaben (UNII: 14255EXE39)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-412-02	1 in 1 CARTON	08/13/2021
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/13/2021

Labeler - Genomma Lab USA (832323534)