Dragon®

Dragon®
SPL v1
SPL
SPL Set ID 9206462e-3bf5-4cf8-8bb3-d6de5911e5d1
Route
TOPICAL
Published
Effective Date 2020-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (40 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Water Arnica Montana Flower .alpha.-tocopherol Acetate Polysorbate 80 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-12

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses
  • temporarily relieves the minor aches and pains of muscles and joints associated with:
    • sprains
    • simple backache
    • arthritis
    • strains
    • bruises
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 (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
  • wash hands after use with cool water
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
Active Ingredient

Menthol 4%

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.

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
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)


Structured Label Content

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

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
  • wash hands after use with cool water
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
Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)
  • store at room temperature 20-25°C (68-77°F)
Inactive Ingredients (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? (Questions or comments?)

Call toll free 1-877-994-3666

Monday to Friday, 8 am to 6 pm Central time.

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If (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
Principal Display Panel 56.7 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

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