Active Ingredient
- Capsicum annum fruit extract (capsaicin)
- Lidocaine HCL
- Menthol
- Methyl Salicylate
Lidopro Pain Relief Ointment
FDA Label NDC 80425-0452
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 Of Tennessee, Llc for the product Lidopro Pain Relief (NDC 80425-0452). 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 doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- counterirritant
- anesthetic
- analgesic
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 the eyes and mucous membranes
Stop Use And Ask Doctor If
- condition worsens
- excessive skin
- irritation develops
- symptoms persist for more than 7 days
- symptoms clear up and occur again within 3 days
If Pregnant Or Breast-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 skin, up to 4 times daily
- 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 Ingredient
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?
(800) 224-2048 or [email protected]
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