First Aid Antiseptic Pain Relieving Cream Liquid
FDA Label NDC 83165-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hubei Fanjian Medical Product Co.,ltd for the product First Aid Antiseptic Pain Relieving Cream (NDC 83165-004). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzalkonium chloride 0.13%
Lidocaine hydrochloride 0.5%
Purpose
first aid antiseptic
pain reliever
Uses
first aid to help decrease the risk of infection in minor
• cuts • scrapes • burns • for the temporary relief of pain
Warnings
For external use only
Do Not Use
• in the eyes
• over large areas of the body
• in large quantities, particularly over raw surfaces or blistered areas
Ask A Doctor Before Use If You Have
• deep or puncture wounds • serious burns • animal bites
Stop Use And Ask A Doctor If
• condition persists or gets worse
• you need to use this product for more than 1 week
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children two years of age and older
• clean the affected area apply a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: consult a doctor
Other Information
• Store at room temperature
Inactive Ingredients
Glycerin monostearate, glycerol, purified water
Package Labeling:
Label (Label)
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