Active Ingredients
Menthol ........... 1.5 mg ..... Topical Analgesic
Methyl Salicylate 12.5 mg ..... Topical Analgesic
Coca Lief Gel
FDA Label NDC 84831-096
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Industria Quimico Farmaceutica Sigma Corp. S.r.l. for the product Coca Lief (NDC 84831-096). 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 ingredients, purpose, otc - ask doctor/pharmacist, indications & usage, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - stop use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Temporary relief of aches and pains associated with <Arthritis, Carpal Tunnel, Swelling, Sprains, Brusing and Inflamation
Otc - Ask Doctor/Pharmacist
If you are pregnant, nursing, or have a medical condition consult a healthcare professional before use.
Indications & Usage
For External Use Only
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding consult a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Stop Use
Stop use and consult a doctor if condition worsens or if sympotoms last for more than 7 days, or if condition clears up but occurs again a few days later, or if you dicsover a rash/irritation.
Other Safety Information
Store at 66 to 92 degress Farenheit. Do not leave in direct sunlight.
Dosage & Administration
aPPLY 3 TO 4 TIMES DAILY AS NEEDED
Inactive Ingredients
Trolamine, 95% Isopropyl Alcohol, cellulose, Gycerine, Coca-leaf extract.
* Please review the disclaimer below.
