Otc - Active Ingredient
Menthol 10% MethySalicylate 15%
Pain Relief Cream
FDA Label NDC 87083-013
7 label sections · Submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd for the product Pain Relief (NDC 87083-013). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
for the temporary relief of arthritis pain in the following areas:·hand · wrist ·elbow. foot · ankle. knee
Otc - Keep Out Of Reach Of Children
Keepout of reachof children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Warnings
Wamings
For external use only. Do not use on deep or puncture wounds, animal bites, serious burns, or broken, infected, or irritated skin. If you are allergic to diclofenac sodium or any ingredient in this product, ask a doctor before use. If you have high blood pressure, heart problems, are taking aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), blood thinners, or other medications, ask a doctor before use.
Dosage & Administration
Adults and children 12 years of age and older: Clean and dry the affected area. Apply a thin layer of cream to the affected area and gently rub in until absorbed. Use as directed. Wash hands after use unless the hands are being treated.
Children under 12 years of age: Ask a doctor before use.
Indications & Usage
When using this product:
avoid contact with eyes and mucous membranes
do not apply to wounds, broken skin, or irritated skin
do not bandage or tightly wrap the treated area
do not apply heat or cold packs before or after application
wash hands after use
Stop use and ask a doctor if:
symptoms worsen
symptoms last more than 7 days
symptoms clear up and occur again within a few days
skin irritation, redness, swelling, or an allergic reaction occurs
Inactive Ingredient
Petrolatum, Mineral Oil, Glycerin, Propylene Glycol, Dimethicone, Phenoxyethanol, Wintergreen Oil, Cetearyl Alcohol, Glyceryl Stearate, Polyethylene glycol 100, Allantoin, Panthenol, Capsaicin, Disodium EDTA, Tocopheryl Acetate, Water
* Please review the disclaimer below.
