Red Hot Ointment

Red Hot Ointment
SPL v3
SPL
SPL Set ID d100092c-e10b-2063-e053-2995a90aedb2
Route
TOPICAL
Published
Effective Date 2021-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.5 mg)
Inactive Ingredients
Mineral Oil Paraffin Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

Methyl Salicylate 12.5% Capsaicin 0.025%

Purpose

Counterirritant


Medication Information

Purpose

Counterirritant

Description

Methyl Salicylate 12.5% Capsaicin 0.025%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis. Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.

Warnings

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. For external use only.

Directions

This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.

Questions?

(800) 345-2231

Other Information

This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.

Package Labeling:

Active Ingredients

Methyl Salicylate 12.5%

Capsaicin 0.025%

Inactive Ingredients

Mineral Oil, Paraffin, Petrolatum

Keep This and All Drugs Out of the Reach of Children.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis. Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.

Purpose

Counterirritant

Warnings

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. For external use only.

Directions

This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.

Questions?

(800) 345-2231

Other Information

This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.

Package Labeling:

Active Ingredients

Methyl Salicylate 12.5%

Capsaicin 0.025%

Inactive Ingredients

Mineral Oil, Paraffin, Petrolatum

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)


Advanced Ingredient Data


Raw Label Data

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