Active Ingredients
Menthol 2%
Pain Relieving Analgesic
FDA Label NDC 52920-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Singhfam Corporation for the product Pain Relieving Analgesic (NDC 52920-123). 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, uses, directions, warnings, do not use, inactive ingredients, 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 temporary relief of minor aches and muscles pain: simple back aches, sprains and strains common to sports activities, joint pains associated with arthritis.
Directions
Clean skin of all other lotions, creams, ointments, liniments: Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times within a 24 hour period. No protective cover needed. Do not apply to children under 2 years of age.
Warnings
Use only as directed.
Do Not Use
with heating pads or heating devices.
Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.
Inactive Ingredients
Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Mathylisothiazolinone, FD&C Blue #1.
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