Active Ingredient
Capsaicin 0.0325%
Lidocaine HCL 4%
Menthol 10%
Methyl Salicylate 27.5%
Lidopro
FDA Label NDC 53217-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Lidopro (NDC 53217-153). 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, when using this product, 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
Topical Analgesic
Topical Analgesic
Topical Analgesic
Topical Analgesic
Uses:
Temporarily relieves minor aches and muscles pains associated with:
- arthritis
- simple back pain
- strains
- muscle soreness
Warnings
For external use only
Do Not Use
- on open wounds, cuts, damaged or infected skin
- with bandage or a heating pad
- if condition worsens or symptoms persists for more than 7 days
- excessive skin irritation occurs
Ask A Doctor Before Use If
- you are allergic to any ingredients, PABA, aspirin products or sulfa
When Using This Product
- avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.
Store
at 20○C - 25○C (68○F - 77○F)
Directions
Adults 18 years and children 12 years and older:
- apply product directly to affected area
- product may be used as necessary, but should not be used more than four times per day.
- wash hands immediately afterwards
Children 12 years or younger: ask a doctor
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.
For Questions Or Comments
Please Email [email protected]
Manufactured for
Terrain Pharmaceuticals
Reno, NV 89501
Made in the U.S.A.
Patent Pending
Principal Display Panel
SPL Label
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