18b24d75-17f7-1a35-e063-6394a90a55e0

SPL v4
SPL
SPL Set ID 18b24d75-17f7-1a35-e063-6394a90a55e0
Route
topical
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.667 g)
Inactive Ingredients
undecylenic acid origanum majorana propanediol sorbitan olivate copaifera officinalis resin oil phenylethyl alcohol glyceryl monocaprylate shea butter cocoa butter simmondsia chinensis seed pentylene glycol cetostearyl alcohol cetearyl olivate water glycerin stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-11

Description

Menthol 2.667%


Medication Information

Warnings and Precautions



Warnings

For external use only. Avoid contact with the eyes. Do not apply • to wounds • on damaged skin • and bandage tightly. Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.

Active Ingredient

Menthol 2.667%

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Dosage and Administration

Directions For people aged 13 and above: Apply to affected area not more than 3-4 times daily.

Description

Menthol 2.667%

Section 44425-7

Store at room temperature and protect from light.

Section 50565-1

Keep out of reach of children

Section 50566-9

Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.

Section 50567-7

For external use only. Avoid contact with the eyes.

Section 50570-1

Do not apply • to wounds • on damaged skin • and bandage tightly.

Section 51727-6



Inactive Ingredients Butyrospermum parkii (shea) butter, cetearyl alcohol, cetearyl olivate, copaifera officinalis (balsam copaiba) resin oil, glycerin, glyceryl caprylate, glyceryl undecylenate, origanum majorana (marjoram) leaf oil, pentylene glycol, phenethyl alcohol, propanediol, simmondsia chinensis (jojoba) seed oil, sorbitan olivate, stearic acid, theobroma cacao (cocoa) seed butter, water.

Section 51945-4

Section 55105-1

topical analgesic


Structured Label Content

Warnings and Precautions (34071-1)



Warnings

For external use only. Avoid contact with the eyes. Do not apply • to wounds • on damaged skin • and bandage tightly. Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.

Active Ingredient (55106-9)

Menthol 2.667%

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Dosage and Administration (34068-7)

Directions For people aged 13 and above: Apply to affected area not more than 3-4 times daily.

Section 44425-7 (44425-7)

Store at room temperature and protect from light.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.

Section 50567-7 (50567-7)

For external use only. Avoid contact with the eyes.

Section 50570-1 (50570-1)

Do not apply • to wounds • on damaged skin • and bandage tightly.

Section 51727-6 (51727-6)



Inactive Ingredients Butyrospermum parkii (shea) butter, cetearyl alcohol, cetearyl olivate, copaifera officinalis (balsam copaiba) resin oil, glycerin, glyceryl caprylate, glyceryl undecylenate, origanum majorana (marjoram) leaf oil, pentylene glycol, phenethyl alcohol, propanediol, simmondsia chinensis (jojoba) seed oil, sorbitan olivate, stearic acid, theobroma cacao (cocoa) seed butter, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

topical analgesic


Advanced Ingredient Data


Raw Label Data

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