Wellmetech Pharmaceutical Industries Sdn Bhd

SPL v33023

SPL

SPL Set ID a5801566-6bbe-44f6-8761-9c1ce3096900

Route

TOPICAL

Published

Effective Date 2025-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (natural) (5 g) Menthol (10 g) Salicylic Acid (23.5 g)

Inactive Ingredients

Paraffin Microcrystalline Wax Eucalyptus Globulus Oil Nutmeg Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-07

Description

Camphor 5% Menthol 10% Methyl Salicylate 23.5%

Purpose

Menthol External Analgesic Camphor External Analgesic Methyl Salicylate External Analgesic

Storage and Handling

Keep container tightly closed at 30°C (86°F).

Medication Information

Purpose

Menthol External Analgesic

Camphor External Analgesic

Methyl Salicylate External Analgesic

Storage and Handling

Keep container tightly closed at 30°C (86°F).

Description

Camphor 5% Menthol 10% Methyl Salicylate 23.5%

Uses

Temporary relief of minor aches and pains of muscle and joint due to:

Simple backache arthritis
Arthritis
Muscle strains
Sprains
Bruises

Section 51945-4

Warnings

For external use only.

Directions

Adult and chldren over 2 years old, rub well on the affected area not more than 3-4 times a day.
For children under 2 years old, consult a doctor before use.

Imported By

Edmark USA, INC

1175-147th Ave, Wayland, MI 49348

[email protected]

Product of Malaysia

Manufacturer:

Wellmetech Pharmaceutical Industries Sdn. Bhd.

Lot 8058, Kota Samarahan Industrial Park, 94300 Samarahan, Malaysia

Active Ingredient

Camphor 5%

Menthol 10%

Methyl Salicylate 23.5%

Inactive Ingredient

Paraffin, Microcrystalline Wax, Eucalyptus Globulus Oil, Nutmeg Oil

When Using This Product

Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly.
Do not use on wounds or damaged skin or with heat source.

Stop Use and Ask A Doctor If

Condition worse.
Severe skin irritation occurs.
Symptoms persist for more than 7 days.
Symptoms clear up and occur again within a few days.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breastfeeding, ask a health professional before use.

Structured Label Content

Uses

Temporary relief of minor aches and pains of muscle and joint due to:

Simple backache arthritis
Arthritis
Muscle strains
Sprains
Bruises

Section 51945-4 (51945-4)

Purpose

Menthol External Analgesic

Camphor External Analgesic

Methyl Salicylate External Analgesic

Warnings

For external use only.

Directions

Adult and chldren over 2 years old, rub well on the affected area not more than 3-4 times a day.
For children under 2 years old, consult a doctor before use.

Imported By (Imported by)

Edmark USA, INC

1175-147th Ave, Wayland, MI 49348

[email protected]

Product of Malaysia

Manufacturer:

Wellmetech Pharmaceutical Industries Sdn. Bhd.

Lot 8058, Kota Samarahan Industrial Park, 94300 Samarahan, Malaysia

Active Ingredient

Camphor 5%

Menthol 10%

Methyl Salicylate 23.5%

Inactive Ingredient (Inactive ingredient)

Paraffin, Microcrystalline Wax, Eucalyptus Globulus Oil, Nutmeg Oil

Storage and Handling (Storage and handling)

Keep container tightly closed at 30°C (86°F).

When Using This Product (When using this product)

Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly.
Do not use on wounds or damaged skin or with heat source.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Condition worse.
Severe skin irritation occurs.
Symptoms persist for more than 7 days.
Symptoms clear up and occur again within a few days.

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.
If pregnant or breastfeeding, ask a health professional before use.

Advanced Ingredient Data

[{"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "23.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS GLOBULUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NUTMEG OIL", "unii": "Z1CLM48948", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": " Temporary relief of minor aches and pains of muscle and joint due to: Simple backache arthritis Arthritis Muscle strains Sprains Bruises", "Purpose": "Menthol External Analgesic Camphor External Analgesic Methyl Salicylate External Analgesic", "Warnings": "For external use only.", "Directions": "Adult and chldren over 2 years old, rub well on the affected area not more than 3-4 times a day. For children under 2 years old, consult a doctor before use.", "Imported by": "Edmark USA, INC 1175-147th Ave, Wayland, MI 49348 customerservice@edmarkusa.com Product of Malaysia", "Manufacturer:": "Wellmetech Pharmaceutical Industries Sdn. Bhd. Lot 8058, Kota Samarahan Industrial Park, 94300 Samarahan, Malaysia", "Active Ingredient": "Camphor 5% Menthol 10% Methyl Salicylate 23.5%", "Inactive ingredient": "Paraffin, Microcrystalline Wax, Eucalyptus Globulus Oil, Nutmeg Oil", "Storage and handling": "Keep container tightly closed at 30°C (86°F).", "When using this product": "Use only as directed. Avoid contact with eyes and mucous membranes. Do not bandage tightly. Do not use on wounds or damaged skin or with heat source.", "Stop use and ask a doctor if": "Condition worse. Severe skin irritation occurs. Symptoms persist for more than 7 days. Symptoms clear up and occur again within a few days.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:55.685513 · Updated: 2026-03-14T23:11:56.566307