SPL v1
SPL
SPL Set ID 460c376c-3026-2460-e063-6394a90a0089
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (6 g) Camphor, (-)- (3.1 g) Salicylic Acid (10 g)
Inactive Ingredients
Mineral Oil Polyisobutylene 35-39 Aluminum Silicate Terpene Resin Styrene/isoprene/styrene Block Copolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-16

Description

ACTIVEINGREDIENTS PURPOSE CamphorMenthol 3.1% Topical analgesicTopical analgesicTopical analgesic 6.0% Methyl salicylate 10.0%


Medication Information

Warnings and Precautions

1.For external use only.

2.Allergy alert: lf prone to allergic reaction from aspirin or salicylates, consult a doctor before use3.Do not use: On wounds or damaged skin. With a heating pad. lf you are allergic to anyingredients of this product.

4.When using this product: Use only as directed. Avoid contact with the eyes. mucousmembranes or rashes. Do not bandage tightly

5.Stop using it and ask a doctor if: Skin reactions such as redness, itching, rash, excessiveirritation, burning sensation,swelling or blistering occur. Conditions worsen.Symptomspersist for more than 7 days. Symptoms clear up and occur again within a few days6.Pregnancy/breast-feeding warning: lf pregnant or breast-feeding, ask a healthprofessional before use.

Indications and Usage

DIRECTIONS

Adults and children 12 years of age and over:1. Clean and dry affected area. 2. Remove patch from film. 3. Apply to affected areas not morethan 3 to 4 times daily. 4. Remove patch from the skin after at most 8-hour application.

Dosage and Administration

Apply to affected areas not morethan 3 to 4 times daily.

Remove patch from the skin after at most 8-hour application.

Description

ACTIVEINGREDIENTS PURPOSE CamphorMenthol 3.1% Topical analgesicTopical analgesicTopical analgesic 6.0% Methyl salicylate 10.0%

Section 50565-1

Keep out of children to reach

Section 51727-6

MINERAL OIL, PERFUME,POLYISOBUTYLENE, STYRENE-ISOPRENE-STYRENE BLOCK COPOLYMER.

SYNTHETIC ALUMINUM SILICATE,TERPENE RESIN, TITANIUM DIOXIDE.

Section 51945-4

Section 55105-1

For temporary relief of minor aches & pains of muscles & joints associated with:Arthritis, Simple backache, Strains, Bruises, Sprains

Section 55106-9

ACTIVEINGREDIENTS

PURPOSE

CamphorMenthol

3.1%

Topical analgesicTopical analgesicTopical analgesic

6.0%

Methyl salicylate 10.0%


Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS

Adults and children 12 years of age and over:1. Clean and dry affected area. 2. Remove patch from film. 3. Apply to affected areas not morethan 3 to 4 times daily. 4. Remove patch from the skin after at most 8-hour application.

Dosage and Administration (34068-7)

Apply to affected areas not morethan 3 to 4 times daily.

Remove patch from the skin after at most 8-hour application.

Warnings and Precautions (34071-1)

1.For external use only.

2.Allergy alert: lf prone to allergic reaction from aspirin or salicylates, consult a doctor before use3.Do not use: On wounds or damaged skin. With a heating pad. lf you are allergic to anyingredients of this product.

4.When using this product: Use only as directed. Avoid contact with the eyes. mucousmembranes or rashes. Do not bandage tightly

5.Stop using it and ask a doctor if: Skin reactions such as redness, itching, rash, excessiveirritation, burning sensation,swelling or blistering occur. Conditions worsen.Symptomspersist for more than 7 days. Symptoms clear up and occur again within a few days6.Pregnancy/breast-feeding warning: lf pregnant or breast-feeding, ask a healthprofessional before use.

Section 50565-1 (50565-1)

Keep out of children to reach

Section 51727-6 (51727-6)

MINERAL OIL, PERFUME,POLYISOBUTYLENE, STYRENE-ISOPRENE-STYRENE BLOCK COPOLYMER.

SYNTHETIC ALUMINUM SILICATE,TERPENE RESIN, TITANIUM DIOXIDE.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For temporary relief of minor aches & pains of muscles & joints associated with:Arthritis, Simple backache, Strains, Bruises, Sprains

Section 55106-9 (55106-9)

ACTIVEINGREDIENTS

PURPOSE

CamphorMenthol

3.1%

Topical analgesicTopical analgesicTopical analgesic

6.0%

Methyl salicylate 10.0%


Advanced Ingredient Data


Raw Label Data

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