SPL v1
SPL
SPL Set ID d7b29a1d-ef20-4332-8c3a-309d8fed6fd6
Route
TOPICAL
Published
Effective Date 2021-02-22
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
Isopropyl Alcohol Liquefied Petroleum Gas Propylene Glycol Turpentine Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-02-23

Description

Capsicum oleoresin 0.02% ,Eucalyptus Oil 2% ,Menthol 5% ,Methyl salicylate 15%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Capsicum oleoresin 0.02% ,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. Irritation 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. Avoid spraying on face. Avoid inhalation of spray.

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

Extremely Flammable

do not use near heat or flame or while smoking. Avoid long term storage above 104 °F (40 °C)do not puncture or incinerate. Contents

under pressure. Do not store at temperatures above 120 °F (49 °C).

Direction

Adults and children over 12 years : spray affected area up to 4 times daily. product will dry quickly on its own, and

does not need to be rubbed in. Children under 12 years : ask a doctor

Product Label

Other Information

Active Ingredients

Capsicum oleoresin 0.02% ,Eucalyptus Oil 2% ,Menthol 5% ,Methyl salicylate 15%

Inactive Ingredient

Isopropyl alcohol, propellant, propylene glycol, 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. Irritation 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. Avoid spraying on face. Avoid inhalation of spray.

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

Extremely Flammable

do not use near heat or flame or while smoking. Avoid long term storage above 104 °F (40 °C)do not puncture or incinerate. Contents

under pressure. Do not store at temperatures above 120 °F (49 °C).

Direction

Adults and children over 12 years : spray affected area up to 4 times daily. product will dry quickly on its own, and

does not need to be rubbed in. Children under 12 years : ask a doctor

Product Label (Product label)

Other Information (Other information)

Active Ingredients (Active ingredients)

Capsicum oleoresin 0.02% ,Eucalyptus Oil 2% ,Menthol 5% ,Methyl salicylate 15%

Inactive Ingredient

Isopropyl alcohol, propellant, propylene glycol, 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)