10e15734-9783-4153-b7b6-a4d0f57678b6

SPL v4
SPL
SPL Set ID 10e15734-9783-4153-b7b6-a4d0f57678b6
Route
topical
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (40 g)
Inactive Ingredients
peanut oil

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2023-03-03

Description

Active ingredient: Methyl Salicylate 40%


Medication Information

Warnings and Precautions

Warning: For external use only. DO NOT USE IF ALLERGIC TO PEANUTS

Active Ingredient

Active ingredient: Methyl Salicylate 40%

Indications and Usage

Uses: Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, bruises.

Dosage and Administration

Directions: Adults and children 12 years of age and older; apply generously to affected area. Massage vigorously into painful areas until absorbed completely. Repeat as needed, but do not use more than three times daily. Children under 12 years of age, ask a doctor.

Other information: Store at room tempreature. Protect from light and heat. Close cap tightly after use.

Description

Active ingredient: Methyl Salicylate 40%

Principal Display Panel

NDC: 81877-620-04            4 Fluid oz. (118 ml)

Methyl

Salicylate 40%

Topical Rubbing Oil

For Temporary Relief of Minor Pains.

DO NOT USE IF ALLERGIC TO PEANUTS

Forreal Pharmaceuticals LLC

YOUR SOLUTION TO BETTER HEALTHCARE

Section 50565-1

Keep out of reach of children. if swallowed, get medical help or contract a Poison Control Center immediately.

Section 50566-9

Stop use and ask doctor if symptoms last more than 7 days or clear up and occur again within a few days. Or condition worsens or rash or irritation develops.

Section 50567-7

When using the product: Do not use in or near the eyes or mucous membranes; if the product gets into the eyes, rinse thoroughly with cold water. Do not bandage tightly or use with hot pads.

Section 50569-3

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate or peanuts.

Section 51727-6

Inactive ingredient: Peanut Oil.

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067


Question or Comments please call 877-367-3250

Section 53414-9

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

Section 55105-1

Purpose: Topical Analgesic


Structured Label Content

Warnings and Precautions (34071-1)

Warning: For external use only. DO NOT USE IF ALLERGIC TO PEANUTS

Active Ingredient (55106-9)

Active ingredient: Methyl Salicylate 40%

Indications and Usage (34067-9)

Uses: Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, bruises.

Dosage and Administration (34068-7)

Directions: Adults and children 12 years of age and older; apply generously to affected area. Massage vigorously into painful areas until absorbed completely. Repeat as needed, but do not use more than three times daily. Children under 12 years of age, ask a doctor.

Other information: Store at room tempreature. Protect from light and heat. Close cap tightly after use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 81877-620-04            4 Fluid oz. (118 ml)

Methyl

Salicylate 40%

Topical Rubbing Oil

For Temporary Relief of Minor Pains.

DO NOT USE IF ALLERGIC TO PEANUTS

Forreal Pharmaceuticals LLC

YOUR SOLUTION TO BETTER HEALTHCARE

Section 50565-1 (50565-1)

Keep out of reach of children. if swallowed, get medical help or contract a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if symptoms last more than 7 days or clear up and occur again within a few days. Or condition worsens or rash or irritation develops.

Section 50567-7 (50567-7)

When using the product: Do not use in or near the eyes or mucous membranes; if the product gets into the eyes, rinse thoroughly with cold water. Do not bandage tightly or use with hot pads.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate or peanuts.

Section 51727-6 (51727-6)

Inactive ingredient: Peanut Oil.

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067


Question or Comments please call 877-367-3250

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose: Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)