Top Medicated Oil

SPL v1

SPL

SPL Set ID eb440866-9a10-44ac-af1d-e76c4733325e

Route

TOPICAL

Published

Effective Date 2012-05-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (natural) (10 mL) Menthol (16 mL) Methyl Salicylate (50 mL)

Inactive Ingredients

Clove Oil Lavender Oil Turpentine Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-05-24

Description

Camphor 10% Menthol 16% Methyl Salicylate 50%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Camphor 10% Menthol 16% Methyl Salicylate 50%

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

simple backache
strains
bruises
arthritis
sprains

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if:

condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

Section 50567-7

When using this product

avoid contact with the eyes or mucous membranes
do not bandage tightly

Section 50570-1

Do not use

on wounds
on irritated or damaged skin
otherwise than as directed

Warnings

For external use only

Directions

adults and children 3 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.
children under 3 years of age: consult your physician.
refer to the above warnings; use otherwise than as directed may be dangerous.

Other Information

store at 16 to 30 degrees C (16 to 86 degrees F)
preserve in tight container

Top Medicated Oil

Active Ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Inactive Ingredients

Clove Oil
Lavender Oil
Turpentine Oil

Top Medicated Oil 1.7oz/50ml (67473 601 01)

Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

simple backache
strains
bruises
arthritis
sprains

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes or mucous membranes
do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds
on irritated or damaged skin
otherwise than as directed

Purpose

External Analgesic

Warnings

For external use only

Directions

adults and children 3 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.
children under 3 years of age: consult your physician.
refer to the above warnings; use otherwise than as directed may be dangerous.

Other Information

store at 16 to 30 degrees C (16 to 86 degrees F)
preserve in tight container

Top Medicated Oil

Active Ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Inactive Ingredients

Clove Oil
Lavender Oil
Turpentine Oil

Top Medicated Oil 1.7oz/50ml (67473 601 01) (Top Medicated Oil 1.7oz/50ml (67473-601-01))

Advanced Ingredient Data

[{"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "16", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAVENDER OIL", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TURPENTINE OIL", "unii": "C5H0QJ6V7F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves minor aches and pains of muscles and joints due to: simple backache strains bruises arthritis sprains", "50565-1": "Keep out of reach of children IF swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if: condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs", "50567-7": "When using this product avoid contact with the eyes or mucous membranes do not bandage tightly", "50570-1": "Do not use on wounds on irritated or damaged skin otherwise than as directed", "Purpose": "External Analgesic", "Warnings": "For external use only", "Directions": "adults and children 3 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations. children under 3 years of age: consult your physician. refer to the above warnings; use otherwis e than as directed may be dangerous.", "Other Information": "store at 16 to 30 degrees C (16 to 86 degrees F) preserve in tight container", "Active Ingredients": "Camphor 10% Menthol 16% Methyl Salicylate 50%", "Inactive Ingredients": "Clove Oil Lavender Oil Turpentine Oil"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:28.605939 · Updated: 2026-03-14T22:53:08.969860