Otc - Active Ingredient
Active Ingredient
Natural L-menthol 2%
Therapain Plus Liquid
FDA Label NDC 58418-827
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Epic Laboratories, Llc for the product Therapain Plus (NDC 58418-827). 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, warnings and precautions, otc - stop use, otc - keep out of reach of children, dosage & administration, 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:
Relieves temporary pains due to:
- Arthritis
- Stiffness
- Sprains and Strains
- Neck and barckaches
- Muscle Soreness
- Cramps
Warnings
Warnings:
FOR EXTERNAL USE ONLY
Warnings And Precautions
Flammable, Avoid
- heat
- sparks
- open flame
- Avoid contact with eyes, mouth, genitalia, mucous membrane, irritated and very sensitive skin
- Do not apply to open wounds or damaged skin.
- Do not bandage tightly.
- Do not. use if you are diabetic or have impaired circulation
When using this product
Otc - Stop Use
Stop use and ask a doctor if
- Excessive skin irritation develops
- Condition worsens.
- Symptoms persist more than 7 days, discontinue use of this product and consult a doctor
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Dosage & Administration
Directions:
- Shake well
- Roll-on liberally to affected area not more than 3 to 4 times daily. Wash hands with soap and water after applying.
- Children under 12years of age: consult a physician.
- After first coat absorbs into skin, re-apply 1-3 extra coats to increase effectiveness.
- Formula dries quickly and won't stain clothes or leave skin lingering with an unplesant medicine scent.
Inactive Ingredient
Other ingredients
Deionized Water, Isopropyl Alcohol, Methyl Sulfonyl Methane (MSM)**,
Glucosamine Sulfate**, Oil of Peppermint, Oil of Eucalyptus,
**For Use as a Skin Conditioner
Otc - Questions
Questions or Comments:
Call toll free: 800-667-1969
Relief-Mart, Inc.
28505 Canwood St. Ste. C
Agoura Hills, CA 93101
www.TherapainPlus.com
* Please review the disclaimer below.
