Dragon With Arnical Pain Relief Gel 2 Oz 5621 Zdp

Dragon With Arnical Pain Relief Gel 2 Oz 5621 Zdp
SPL v9
SPL
SPL Set ID b4cbb7b6-cb71-9721-e053-2995a90a2b2c
Route
TOPICAL
Published
Effective Date 2020-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Camphor (synthetic) Carbomer Homopolymer, Unspecified Type Isopropyl Alcohol Fd&c Blue No. 1 Water Fd&c Yellow No. 5 Polysorbate 80 Potassium Sorbate Trolamine Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-23
Description

Active ingredient Purpose Menthol 4%.......................................................Topical analgesic

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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
Dosage and Administration

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

Description

Active ingredient Purpose Menthol 4%.......................................................Topical analgesic

Section 44425-7

Other information

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

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 50566-9

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
Section 50567-7

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50569-3

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

Section 50570-1

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
Section 51727-6

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

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

  • temporarily relieves the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthirtis
  • strains bruises
Section 55106-9

Active ingredient Purpose

Menthol 4%.......................................................Topical analgesic

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

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

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 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

  • temporarily relieves the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthirtis
  • strains bruises
Section 55106-9 (55106-9)

Active ingredient Purpose

Menthol 4%.......................................................Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:18.533368 · Updated: 2026-03-14T23:13:21.652895