Otc - Active Ingredient
Active ingredient: Methyl Salicylate 40%
Methyl Salicylate 40% Topical Oil Liquid
FDA Label NDC 81877-620
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Forreal Pharmaceuticals Llc for the product Methyl Salicylate 40% Topical Oil (NDC 81877-620). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Topical Analgesic
Indications & Usage
Uses: Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, bruises.
Warnings
Warning: For external use only. DO NOT USE IF ALLERGIC TO PEANUTS
Otc - Ask Doctor
Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate or peanuts.
Otc - When Using
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.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if swallowed, get medical help or contract a Poison Control Center immediately.
Dosage & 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.
Inactive Ingredient
Inactive ingredient: Peanut Oil.
Packaged For:
Forreal Pharmaceuticals LLC
Royal Oak, MI 48067
Question or Comments please call 877-367-3250
Principal Display Panel
NDC: 81877-602-04 4 Fluid oz.
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
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