Active Ingredient
Menthol 4%
Md80 Clinical Strength Topical Analgesic
FDA Label NDC 80967-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Sherpa North America Llc for the product Md80 Clinical Strength Topical Analgesic (NDC 80967-004). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with:
- simple backache
- strains
- sprains
- bruises
- arthritis
Warnings
For external use only.
Do Not Use
- on large areas of the body
- with other ointments, creams, sprays or liniments
- with heating pad
Ask A Doctor Before Use If You Have
sensitive skin or redness over the affected area
When Using This Product
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged skin
- do not bandage
- wash hands after use
Stop Use And Ask A Doctor If
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children.
If accidentally ingested, get medical help or contact a Poison Control Center immediately.
Directions
- Use only as directed
- Adults and children over 12 years: apply to affected area not more than 4 times daily.
- Children under 12 years of age: Consult physician.
Other Information
Store in cool dry place
Inactive Ingredients
Alcohol Denat., Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Butylene Glycol, Diethyl Nonanedioate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Alcohol, Methyl Hydroxypropyl Cellulose, Polyacrylate Crosspolymer 6, Polysorbate 20, Water
Questions?
1-806-319-8845 or md80relief.com
Company Information
Distributed by Skin Sherpa North America, LLC, 18756 Stone Oak Pkwy, Ste. 200 San Antonio, TX 78258
www.md80relief.com
Product Packaging
Md80 (Md80)
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