Active Ingredient
Menthol 5% (w/w)
Puvida Numbing Cream
FDA Label NDC 85248-172
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Puvida Numbing (NDC 85248-172). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
For the temporary relief of pain and itching associated with minor burns, sunburn, insect bites and minor skin irritation
Warnings
·For external use only
·If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
·Do not use in large quantities, particularly over raw surfaces or blistered areas
·Avoid contact with eyes. If this happens, rinse thoroughly with water
Do Not Use
·Do not use in large quantities, particularly over raw surfaces or blistered areas
When Using
·Avoid contact with eyes, lf this happens, rinse thoroughly with water.
Stop Use
·Condition worsens or does not improve within 7 days
·Allergic reaction occurs to ingredients in this product
·Symptom being treated does not subside or if redness, irritation
Ask Doctor
·Condition worsens or does not improve within 7 days
·Allergic reaction occurs to ingredients in this product
·Symptom being treated does not subside or if redness, irritation
Keep Oot Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use
Directions
Adults and children 2 years of age and older:
Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a doctor
Other Information
Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).
Inactive Ingredients
Water, Carbomer 934, Propylene Glycol, Soybean Lecithin, Alpha-Tocopherol Acetate, Benzyl Alcohol.
Package Label.Principal Display Panel
5 (Db07d74be952fc2fe1c5620b46113bb7)
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