Active Ingredient
Capsaicin 0.0325%
Lidocaine HCL 4%
Menthol 10%
Methyl Salicylate 27.5%
Lidopro
FDA Label NDC 80425-0332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Pharmacy Of Tennessee, Llc for the product Lidopro (NDC 80425-0332). 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, when using this product:, stop use and ask a doctor if:, if pregnant orbreast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Counterirritant
Topical Anesthetic
Topical Analgesic
Counterirritant
Uses
For the temporary relief of joint pain and muscle pain associated with:
- Arthritis
- Simple Backache
- Muscle Sprains
- Muscle Strains
Warnings
For External Use Only
Do Not Use
- On damaged, irritated, or infected skin
- With a bandage or heating pad
- If you are allergic to any ingredients in this product
When Using This Product:
Avoid contact with eyes and mucus membranes
Stop Use And Ask A Doctor If:
- Conditions worsens
- Excessive skin irritation develops
- Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days
If Pregnant Orbreast-Feeding:
Ask a health professional before use.
Keep Out Of Reach Of Children:
If ingested seek medical help or contact a Poison Control Center immediately
Flammable:
Keep away from excessive heat or open flame
Directions
Adults and Children 12 Years of Age and Older:
- Clean and dry the affected area
- Apply product directly to your skin, up to 4 times daily affected area
- Wash hands immediately after use
Children Under 12 Years of Age: Consult physician
Other Information
- Store in a cool, dry place with lid tightly closed
- If the tamper-evident foil seal is not intact, do not use
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.
Questions Or Comments?
How Supplied
LidoPro Oinment is supplied as follows:
Ointent Tube of 92g NDC: 80425-0332-01
* Please review the disclaimer below.
