Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID bdc48a36-d6da-4ecf-a2a7-fe9ef9049f00

Route

TRANSDERMAL

Published

Effective Date 2014-05-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Salicylic Acid (3 g)

Inactive Ingredients

Menthol Camphor (synthetic) Diphenhydramine Hydrochloride Dibucaine Hydrochloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-05-16

Description

methyl salicylate

Medication Information

Warnings and Precautions

avoid contact with eyes, if this product splashes in to your eyes, wash immediately with water

Indications and Usage

apply to the affected area once to several times a day

Dosage and Administration

for external use only

Description

methyl salicylate

Section 50565-1

keep out or reach of the children

Section 51727-6

camphor, menthol, glycyrrhetic acid, diphenhydramine hcl, dibucaine hcl

Section 51945-4

Section 55105-1

aczema, dermatitis, erosion, miliaria, pruritus, pernio, insect bite, hives

Section 55106-9

methyl salicylate

Structured Label Content

Indications and Usage (34067-9)

apply to the affected area once to several times a day

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

avoid contact with eyes, if this product splashes in to your eyes, wash immediately with water

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

camphor, menthol, glycyrrhetic acid, diphenhydramine hcl, dibucaine hcl

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

aczema, dermatitis, erosion, miliaria, pruritus, pernio, insect bite, hives

Section 55106-9 (55106-9)

methyl salicylate

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "unii": "TC2D6JAD40", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBUCAINE HYDROCHLORIDE", "unii": "Z97702A5DG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "apply to the affected area once to several times a day", "34068-7": "for external use only", "34071-1": "avoid contact with eyes, if this product splashes in to your eyes, wash immediately with water", "50565-1": "keep out or reach of the children", "51727-6": "camphor, menthol, glycyrrhetic acid, diphenhydramine hcl, dibucaine hcl", "55105-1": "aczema, dermatitis, erosion, miliaria, pruritus, pernio, insect bite, hives", "55106-9": "methyl salicylate"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:47.802602 · Updated: 2026-03-14T22:53:45.227062