SPL v1
SPL
SPL Set ID 45cf4040-9751-d24b-e063-6294a90aff27
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mint (1 g) Camphor, (-)-
Inactive Ingredients
Menthol Powdered Cellulose Borneol Cotton Fiber Capsicum Oleoresin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Active ingredient. camphor Mint


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Adult and children 12 years of age and older:

peel off protective backing and apply sticky side to affected area

carefully remove backing from patch

should be used to 8 hours

ashould be used no more than 3 times a day

Children under 12 years of age: consult a doctor

Dosage and Administration

should be used to 8 hours

ashould be used no more than 3 times a day

Description

Active ingredient. camphor Mint

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 51727-6

Water cotton , paper

hotmelt adhesive, chili oil, borneol camphor menthol

Section 51945-4

Section 55105-1

emporarily relieves minor pain associated with:

arthritis cimpie backache bursitis tendonitis muscle streins epreins bruises cramps

Section 55106-9

Active ingredient.

camphor

Mint


Structured Label Content

Indications and Usage (34067-9)

Adult and children 12 years of age and older:

peel off protective backing and apply sticky side to affected area

carefully remove backing from patch

should be used to 8 hours

ashould be used no more than 3 times a day

Children under 12 years of age: consult a doctor

Dosage and Administration (34068-7)

should be used to 8 hours

ashould be used no more than 3 times a day

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 51727-6 (51727-6)

Water cotton , paper

hotmelt adhesive, chili oil, borneol camphor menthol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

emporarily relieves minor pain associated with:

arthritis cimpie backache bursitis tendonitis muscle streins epreins bruises cramps

Section 55106-9 (55106-9)

Active ingredient.

camphor

Mint


Advanced Ingredient Data


Raw Label Data

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