83781-006 Update V2

SPL v2

SPL

SPL Set ID 0978ff22-c357-e266-e063-6394a90a98a4

Route

TOPICAL

Published

Effective Date 2025-03-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Levomenthol (5.7 g) Salicylic Acid (6.3 g) Camphor (synthetic) (1.2 g) .alpha.-tocopherol (2 g)

Inactive Ingredients

Gynostemma Pentaphyllum Leaf Flemingia Prostrata Whole Cinnamon Oil Clove Panax Notoginseng Root

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-05

Description

DL-Camphor 1.2% L-Menthol 5.7% Methyl Salicylate 6.3% Tocopherol Acetate 2%

Purpose

Relieve pain Labor pains, relieve itching Relieve pain and inflammation Protect the skin

Medication Information

Purpose

Relieve pain

Labor pains, relieve itching

Relieve pain and inflammation

Protect the skin

Description

DL-Camphor 1.2% L-Menthol 5.7% Methyl Salicylate 6.3% Tocopherol Acetate 2%

Use

Uses For relief of aches,pains and inflammations associated with:

★Muscle fatigue

★Muscle pain

★Stiff shoulder

★Simple backache

★Bruises

★Bone Fracture

★Minor Frostbite

★Arthritis

Stop Use

Conditions worsen. ★ Symptoms persist for more than 7 days.

★Symptoms clear up and occur again within a few days.

★Rash, itching or excessive skin irritation occurs.

Warnings

Warnings For external use only

Do not use:

★on wounds or damaged skin

★if you are allergic to aspirin or salicylates.

Stop use and ask a doctor if:

★ Conditions worsen.

★ Symptoms persist for more than 7 days.

★Symptoms clear up and occur again within a few days.

★Rash, itching or excessive skin irritation occurs.

Questions

[email protected]

Ask Doctor

Children under 12 years of age

Directions

clean and dry affected area. Remove from backing film and apply to affected area not more than 3 to 4 times daily. Remove after at most 8 hours.

Do Not Use

on wounds or damaged skin ★if you are allergic to aspirin or salicylates.

When Using

Clean, dry affected area. Remove from the backing film and apply to the affected area no more than 3 to 4 times a day. Remove after up to 8 hours.

Active Ingredient

DL-Camphor 1.2%

L-Menthol 5.7%

Methyl Salicylate 6.3%

Tocopherol Acetate 2%

Other Information

★Store below 25 Degrees Celsius. ★ Avoid direct sunlight

Inactive Ingredients

A strip of Root extract、Clover extract、Panax Notoginseng Root Extract、Fairy palm

extract、Cinnamon essential oil

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children

Structured Label Content

Use

Uses For relief of aches,pains and inflammations associated with:

★Muscle fatigue

★Muscle pain

★Stiff shoulder

★Simple backache

★Bruises

★Bone Fracture

★Minor Frostbite

★Arthritis

Purpose

Relieve pain

Labor pains, relieve itching

Relieve pain and inflammation

Protect the skin

Stop Use

Conditions worsen. ★ Symptoms persist for more than 7 days.

★Symptoms clear up and occur again within a few days.

★Rash, itching or excessive skin irritation occurs.

Warnings

Warnings For external use only

Do not use:

★on wounds or damaged skin

★if you are allergic to aspirin or salicylates.

Stop use and ask a doctor if:

★ Conditions worsen.

★ Symptoms persist for more than 7 days.

★Symptoms clear up and occur again within a few days.

★Rash, itching or excessive skin irritation occurs.

Questions

[email protected]

Ask Doctor

Children under 12 years of age

Directions

clean and dry affected area. Remove from backing film and apply to affected area not more than 3 to 4 times daily. Remove after at most 8 hours.

Do Not Use (Do not use)

on wounds or damaged skin ★if you are allergic to aspirin or salicylates.

When Using

Clean, dry affected area. Remove from the backing film and apply to the affected area no more than 3 to 4 times a day. Remove after up to 8 hours.

Active Ingredient

DL-Camphor 1.2%

L-Menthol 5.7%

Methyl Salicylate 6.3%

Tocopherol Acetate 2%

Other Information (Other information)

★Store below 25 Degrees Celsius. ★ Avoid direct sunlight

Inactive Ingredients (Inactive ingredients)

A strip of Root extract、Clover extract、Panax Notoginseng Root Extract、Fairy palm

extract、Cinnamon essential oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children

Advanced Ingredient Data

[{"name": "LEVOMENTHOL", "unii": "BZ1R15MTK7", "classCode": "ACTIB", "strengthNumerator": "5.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "6.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "GYNOSTEMMA PENTAPHYLLUM LEAF", "unii": "5DWS84R85M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "1.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "FLEMINGIA PROSTRATA WHOLE", "unii": "R0GG9QUA0Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CINNAMON OIL", "unii": "E5GY4I6YCZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE", "unii": "K48IKT5321", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANAX NOTOGINSENG ROOT", "unii": "GQX1C1175U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "Uses For relief of aches,pains and inflammations associated with: ★Muscle fatigue ★Muscle pain ★Stiff shoulder ★Simple backache ★Bruises ★Bone Fracture ★Minor Frostbite ★Arthritis", "Purpose": "Relieve pain Labor pains, relieve itching Relieve pain and inflammation Protect the skin", "Stop Use": "Conditions worsen. ★ Symptoms persist for more than 7 days. ★Symptoms clear up and occur again within a few days. ★Rash, itching or excessive skin irritation occurs.", "Warnings": "Warnings For external use only Do not use: ★on wounds or damaged skin ★if you are allergic to aspirin or salicylates. Stop use and ask a doctor if: ★ Conditions worsen. ★ Symptoms persist for more than 7 days. ★Symptoms clear up and occur again within a few days. ★Rash, itching or excessive skin irritation occurs.", "Questions": "mqupin86@gmail.com", "Ask Doctor": "Children under 12 years of age", "Directions": "clean and dry affected area. Remove from backing film and apply to affected area not more than 3 to 4 times daily. Remove after at most 8 hours.", "Do not use": "on wounds or damaged skin ★if you are allergic to aspirin or salicylates.", "When Using": "Clean, dry affected area. Remove from the backing film and apply to the affected area no more than 3 to 4 times a day. Remove after up to 8 hours.", "Active Ingredient": "DL-Camphor 1.2% L-Menthol 5.7% Methyl Salicylate 6.3% Tocopherol Acetate 2%", "Other information": "★Store below 25 Degrees Celsius. ★ Avoid direct sunlight", "Inactive ingredients": "A strip of Root extract、Clover extract、Panax Notoginseng Root Extract、Fairy palm extract、Cinnamon essential oil", "Keep Out Of Reach Of Children": "Keep out of reach of children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.877713 · Updated: 2026-03-14T23:08:04.646392