SPL v2
SPL
SPL Set ID cd2288c4-9909-43c1-91da-b15545b09788
Route
TOPICAL
Published
Effective Date 2021-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (37 g) Camphor (synthetic) (10 g)
Inactive Ingredients
Menthol Turpentine Oil Eucalyptus Oil Lavender Oil Tolu Balsam

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-18
Description

Drug Facts Active Ingredients Methyl Salicylate 37% Camphor 10%

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, clean and dry the affected area, apply 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 37% Camphor 10%

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 bandage tighly
Section 50570-1

Do not use

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

Inactive ingredients

menthol, turpentine oil, eucalyptus oil, lavender oil, tolu balsam

Section 51945-4

Section 53413-1

Question 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 37%

Camphor 10%

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, clean and dry the affected area, apply 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 bandage tighly
Section 50570-1 (50570-1)

Do not use

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

Inactive ingredients

menthol, turpentine oil, eucalyptus oil, lavender oil, tolu balsam

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question 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 37%

Camphor 10%

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: 2026-02-15T12:03:40.891522 · Updated: 2026-03-14T23:03:52.479021