SPL v2
SPL
SPL Set ID 99a13b0a-1d77-479e-ba99-2cfa638de339
Route
TOPICAL
Published
Effective Date 2021-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (22 g) Camphor (synthetic) (2 g)
Inactive Ingredients
Eucalyptus Oil Menthol Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-02
Description

Drug Facts Active Ingredients Methyl Salicylate 22% Camphor 2%

Medication Information

Warnings and Precautions

Warnings

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

Uses

Temporarily relieves minor aches, pains of muscles and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Dosage and Administration

Directions

  • adults and children 12 years and older, apply appropriate amount to the affected area. Apply pressure and massage gently not more than 3 to 4 times daily
  • children under 12 years of age, consult a doctor before using
Description

Drug Facts Active Ingredients Methyl Salicylate 22% Camphor 2%

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
  • do not banage tighly
Section 50570-1

Do not use

  • on opened wounds
  • on damaged skin
Section 51727-6

Inactive ingredients

eucalyptus Oil, menthol, paraffin

Section 51945-4

Section 53413-1

Questions or comments?

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

Section 53414-9

if pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Drug Facts

Active Ingredients

Methyl Salicylate 22%

Camphor 2%

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, pains of muscles and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and older, apply appropriate amount to the affected area. Apply pressure and massage gently not more than 3 to 4 times daily
  • children under 12 years of age, consult a doctor before using
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
  • do not banage tighly
Section 50570-1 (50570-1)

Do not use

  • on opened wounds
  • on damaged skin
Section 51727-6 (51727-6)

Inactive ingredients

eucalyptus Oil, menthol, paraffin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

if pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Methyl Salicylate 22%

Camphor 2%

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: 2026-02-15T12:03:40.846612 · Updated: 2026-03-14T23:03:51.620726