Doloflex Pain Relief

Doloflex Pain Relief
SPL v2
SPL
SPL Set ID 32a830cc-04d3-102e-e063-6294a90a1cad
Route
TOPICAL
Published
Effective Date 2025-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g) Salicylic Acid (10 g)
Inactive Ingredients
Arnica Montana Flower Peg-40 Hydrogenated Castor Oil Dmdm Hydantoin Horse Chestnut Calendula Officinalis Flower Camphor (synthetic) Iodopropynyl Butylcarbamate Triethanolamine Water Alcohol Centella Asiatica Leaf Carbomer 940

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-17

Description

Menthol 2%, Methyl Salicylate 10%


Medication Information

Warnings and Precautions

For external use only.

Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin.

When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes.

Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.

Indications and Usage

Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

Dosage and Administration

Adults and children 12 years of age or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.

Description

Menthol 2%, Methyl Salicylate 10%

Section 50565-1

If swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, alcohol, carbomer, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-40 Hydrogenated Caster Oil, Aesculus Hippocastanum Seed Extract, Centella Assiatica Leaf Extract, Arnica Montana Flowers Oil, Calendula Officinalis Flower Extract, Triethanolamine.

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 2%, Methyl Salicylate 10%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

Dosage and Administration (34068-7)

Adults and children 12 years of age or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.

Warnings and Precautions (34071-1)

For external use only.

Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin.

When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes.

Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, alcohol, carbomer, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-40 Hydrogenated Caster Oil, Aesculus Hippocastanum Seed Extract, Centella Assiatica Leaf Extract, Arnica Montana Flowers Oil, Calendula Officinalis Flower Extract, Triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 2%, Methyl Salicylate 10%


Advanced Ingredient Data


Raw Label Data

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