Dragon®

Dragon®
SPL v1
SPL
SPL Set ID 40c1a66f-a21f-4f81-a072-3bdd1a612ad8
Route
TOPICAL
Published
Effective Date 2021-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg) Camphor, (-)- (40 mg) Salicylic Acid (300 mg)
Inactive Ingredients
Glyceryl Monostearate Water Polysorbate 80 Sorbitan Monooleate Stearic Acid Ethylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-08-13

Description

Drug Facts

Purpose

Topical analgesics


Medication Information

Purpose

Topical analgesics

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.

Section 50569-3

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

Section 53414-9

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

Warnings

For external use only

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

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Allergy Alert
  • If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Other Information
  • Store between 20° and 25° C (68° and 77° F)
Active Ingredients

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

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

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
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)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Purpose

Topical analgesics

Warnings

For external use only

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

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
Allergy Alert (Allergy alert)
  • If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Other Information (Other information)
  • Store between 20° and 25° C (68° and 77° F)
Active Ingredients (Active ingredients)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1 877 994 3666.

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

When Using This Product (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 (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
Principal Display Panel 56.7 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)