SPL v1
SPL
SPL Set ID 3f72e766-3427-5bc4-e063-6394a90aa673
Route
TOPICAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Purslane Hydroxyacetophenone Polyoxyl 40 Hydrogenated Castor Oil 1,2-hexanediol Edetate Disodium Water Carbomer Homopolymer, Unspecified Type Propylene Glycol Glycerin Chrysanthellum Indicum Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-23

Description

Active ingredient : 1% Menthol .… Purpose Topical Analgesic


Medication Information

Warnings and Precautions

Warnings For external use only. Avoid contact with the eyes.

Indications and Usage

Directions Adults: Clean the affected area with mild soap and warmwater and rinse thoroughly, Gently dry by patting with toilettissue or a soft cloth before application of this product.Children under 12 years of age: consult a doctor.

Dosage and Administration

1.Clean hands and treatment area with mild soap andwarm water, rinse thoroughly, then gently pat dry.2.Apply a thick layer of numbing cream to the treatmentarea, making sure to cover both the treatment area andits surroundings.3.Wrap tightly with plastic wrap and wait 40 -60 minutes(Longer time, better effect.)4.Wipe away residue, and wait another 15 -25 minutes forthe numbness to peak.

5.Begin the procedure.

Description

Active ingredient : 1% Menthol .… Purpose Topical Analgesic

Section 50565-1

Keep out of reach of childrenIn case of accidental ingestion, seek medical helpimmediately.

Section 50567-7

When using this product Do not exceed the recommendeddaily dosage unless directed by a doctor. Certain personscan develop allergic reactions to the ingredients in this product.Do not put this product into the rectum by using finger.

Section 51727-6

Water, Propylene glycol, Carbomer Homopolymer, Glycerin,Edetate Disodium,Hydroxyacetophenone, 1,2-Hexanediol,Chrysanthellum Indicum Top, Purslane, Polyoxyl 40hydrogenated castor oil

Section 51945-4

Section 55105-1

UseFor the temporary relief of localized pain, itching ordiscomfort from minor skin irritations.

Section 55106-9

Active ingredient :

1% Menthol .…

Purpose

Topical Analgesic


Structured Label Content

Indications and Usage (34067-9)

Directions Adults: Clean the affected area with mild soap and warmwater and rinse thoroughly, Gently dry by patting with toilettissue or a soft cloth before application of this product.Children under 12 years of age: consult a doctor.

Dosage and Administration (34068-7)

1.Clean hands and treatment area with mild soap andwarm water, rinse thoroughly, then gently pat dry.2.Apply a thick layer of numbing cream to the treatmentarea, making sure to cover both the treatment area andits surroundings.3.Wrap tightly with plastic wrap and wait 40 -60 minutes(Longer time, better effect.)4.Wipe away residue, and wait another 15 -25 minutes forthe numbness to peak.

5.Begin the procedure.

Warnings and Precautions (34071-1)

Warnings For external use only. Avoid contact with the eyes.

Section 50565-1 (50565-1)

Keep out of reach of childrenIn case of accidental ingestion, seek medical helpimmediately.

Section 50567-7 (50567-7)

When using this product Do not exceed the recommendeddaily dosage unless directed by a doctor. Certain personscan develop allergic reactions to the ingredients in this product.Do not put this product into the rectum by using finger.

Section 51727-6 (51727-6)

Water, Propylene glycol, Carbomer Homopolymer, Glycerin,Edetate Disodium,Hydroxyacetophenone, 1,2-Hexanediol,Chrysanthellum Indicum Top, Purslane, Polyoxyl 40hydrogenated castor oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

UseFor the temporary relief of localized pain, itching ordiscomfort from minor skin irritations.

Section 55106-9 (55106-9)

Active ingredient :

1% Menthol .…

Purpose

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)