SPL v1
SPL
SPL Set ID 42190b8a-2c1a-4cdf-8752-120b5dee3b94
Route
TOPICAL
Published
Effective Date 2021-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptus Oil (2 g) Menthol (5 g) Salicylic Acid (15 g)
Inactive Ingredients
Light Mineral Oil Microcrystalline Wax Paraffin Turpentine Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-05

Description

Eucalyptus Oil 2% , Menthol 5% ,Methyl salicylate 15%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Eucalyptus Oil 2% , Menthol 5% ,Methyl salicylate 15%

Uses

For temporary relief of minor aches and pains of muscles and joints due to: simple backaches, bruises, sprains, arthritis

Warning

For external use only.

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.



Stop use and ask a doctor if condition
 worsens or if symptoms persist for more than 7 days or clear up and occurs again within a few days. Redness is present. Excessive irritation of the skin develops.

When using this product

Use only as directed. Avoid contact with the eyes or mucous membranes. Do not apply on wounds and damaged skin. Do not bandage tightly. Do not use with heating pad.

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

Direction

Adults and children 12 years and older: apply to the affected area and massage gently not more than 3 to 4 times daily.

Children under 12 years of age :consult a physician.

Product Label

Other Information

Store at room temperature.

Active Ingredients

Eucalyptus Oil 2% , Menthol 5% ,Methyl salicylate 15%

Inactive Ingredient

Light liquid paraffin, microcrystalline wax, paraffin wax, turpentine oil

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints due to: simple backaches, bruises, sprains, arthritis

Purpose

External Analgesic

Warning

For external use only.

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.



Stop use and ask a doctor if condition
 worsens or if symptoms persist for more than 7 days or clear up and occurs again within a few days. Redness is present. Excessive irritation of the skin develops.

When using this product

Use only as directed. Avoid contact with the eyes or mucous membranes. Do not apply on wounds and damaged skin. Do not bandage tightly. Do not use with heating pad.

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

Direction

Adults and children 12 years and older: apply to the affected area and massage gently not more than 3 to 4 times daily.

Children under 12 years of age :consult a physician.

Product Label (Product label)

Other Information (Other information)

Store at room temperature.

Active Ingredients (Active ingredients)

Eucalyptus Oil 2% , Menthol 5% ,Methyl salicylate 15%

Inactive Ingredient

Light liquid paraffin, microcrystalline wax, paraffin wax, turpentine oil

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)