SPL v2
SPL
SPL Set ID b84c4d33-5a77-46e0-b04e-32f73967bd1c
Route
TOPICAL
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Menthol Sesame Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28
Description

Drug Facts Active Ingredients Methyl Salicylate 1%

Medication Information

Warnings and Precautions

Warnings

  • external use only
  • use only as directed
Indications and Usage

Uses

Temporarily relieves minor aches and pains of muscles, stiffness around the neck and shoulders and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration

Directions

  • adults and children 12 years and older, clean and dry the affected area, and apply to affected area not more than 3 to 4 times daily
  • if you have sensitive skin, try a small piece of the plaster on the arm for 60 minutes before first use. If rash, redness or itching results, discontinue use and consult a doctor
Description

Drug Facts Active Ingredients Methyl Salicylate 1%

Section 50565-1

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if

  • a rash or irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clears up and occur again within a few days
Section 50567-7

When using this product

  • avoid contact with the eyes or mucous membranes
  • highly adhesive plaster may hurt skin upon removal
Section 50569-3

Ask a doctor or pharmacist before use if you are

  • prone to allergic reactions from medicine and/or cosmetic
  • children under 12 years of age, and if you are pregnant or nursing a baby
Section 50570-1

Do Not use

  • on opened wounds
  • on damaged skin
  • eczema
  • hairy surface of skin
Section 51727-6

Inactive ingredients

menthol, sesame Oil

Section 51945-4

Section 53413-1

Questions or comments?

(626) 354 1819 M-F 9am to 5pm

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Drug Facts

Active Ingredients

Methyl Salicylate 1%

Section 60561-8

Other information

  • be stored below 28°C (82°F)
  • closed tightly after used

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor aches and pains of muscles, stiffness around the neck and shoulders and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and older, clean and dry the affected area, and apply to affected area not more than 3 to 4 times daily
  • if you have sensitive skin, try a small piece of the plaster on the arm for 60 minutes before first use. If rash, redness or itching results, discontinue use and consult a doctor
Warnings and Precautions (34071-1)

Warnings

  • external use only
  • use only as directed
Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • a rash or irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clears up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes or mucous membranes
  • highly adhesive plaster may hurt skin upon removal
Section 50569-3 (50569-3)

Ask a doctor or pharmacist before use if you are

  • prone to allergic reactions from medicine and/or cosmetic
  • children under 12 years of age, and if you are pregnant or nursing a baby
Section 50570-1 (50570-1)

Do Not use

  • on opened wounds
  • on damaged skin
  • eczema
  • hairy surface of skin
Section 51727-6 (51727-6)

Inactive ingredients

menthol, sesame Oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

(626) 354 1819 M-F 9am to 5pm

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Methyl Salicylate 1%

Section 60561-8 (60561-8)

Other information

  • be stored below 28°C (82°F)
  • closed tightly after used

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:41.573543 · Updated: 2026-03-14T23:03:53.608631