Rocainol Topical Analgesic Ointment

SPL v10

SPL

SPL Set ID 827ec7b2-3d87-47e0-a47a-966b25732c32

Route

TOPICAL

Published

Effective Date 2019-05-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (16 g) Menthol (8 g)

Inactive Ingredients

Alcohol Phosphate Ion(2-) Water Mineral Oil Sodium Borate Trolamine White Wax Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-09-30

Description

Methyl salicylate 16% Menthol 8%

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Methyl salicylate 16% Menthol 8%

Uses

Temporary relief of minor aches and pains associated with • arthritis • simple backache • bruises • sprains

Warnings

For External use only

Directions

Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor

Do Not Use

on pregnant women and children under 12 years of age unless directed by a doctor

Drug Facts

Do Not Apply

to wounds or damaged skin Do not bandage tightly

Discontinue Use

if excessive irritation of the skin develops

Package Labeling:

Active Ingredients

Methyl salicylate 16% Menthol 8%

Inactive Ingredients

Ethoxylated alcohol, Hydrogen phosphate, distilled water, mineral oil, sodium borate, triethanolamine, white beeswax, white petrolatum

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

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

Structured Label Content

Uses

Temporary relief of minor aches and pains associated with • arthritis • simple backache • bruises • sprains

Purpose

External analgesic

Warnings

For External use only

Directions

Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

on pregnant women and children under 12 years of age unless directed by a doctor

Drug Facts

Do Not Apply (Do not apply)

to wounds or damaged skin Do not bandage tightly

Discontinue Use (Discontinue use)

if excessive irritation of the skin develops

Package Labeling:

Active Ingredients (Active ingredients)

Methyl salicylate 16% Menthol 8%

Inactive Ingredients (Inactive ingredients)

Ethoxylated alcohol, Hydrogen phosphate, distilled water, mineral oil, sodium borate, triethanolamine, white beeswax, white petrolatum

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

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief of minor aches and pains associated with • arthritis • simple backache • bruises • sprains", "Purpose": "External analgesic", "Warnings": "For External use only", "Directions": "Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor", "Do not use": "on pregnant women and children under 12 years of age unless directed by a doctor", "Do not apply": "to wounds or damaged skin Do not bandage tightly", "Discontinue use": "if excessive irritation of the skin develops", "Active ingredients": "Methyl salicylate 16% Menthol 8%", "Inactive ingredients": "Ethoxylated alcohol, Hydrogen phosphate, distilled water, mineral oil, sodium borate, triethanolamine, white beeswax, white petrolatum", "Keep this and all drugs out of the reach of children.": "If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.862901 · Updated: 2026-03-14T23:09:18.179019