Otc - Active Ingredient
BENZALKONIUM CHLORIDE;
PRAMOXINE HYDROCHLORIDE;
First Aid Antiseptic Pain Relieving
FDA Label NDC 82199-610
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Ruian Pharmaceutical Co.,ltd. for the product First Aid Antiseptic Pain Relieving (NDC 82199-610). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
First aid antibiotic
Topical analgesic
Indications & Usage
first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
• cuts
• scrapes
• burns
Warnings
For external use only
Otc - Do Not Use
• in the eyes
• over large areas of the body
Otc - Ask Doctor
• deep or puncture wounds
• animal bites
• serious burns
Otc - Stop Use
• condition or symptoms get worse or last more than one week
• symptoms clear up and occur again within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Centre right away.
Dosage & Administration
• Adults and children 2 years of age and older:
• Clean the affected area
• Spray a small amount of this product on the area 1 to 3 times daily.
• May be covered with a sterile bandage
• If bandaged, let dry first
• Children under 2 years of age: consult a doctor
Other Safety Information
Store at Room Temperature
Inactive Ingredient
Water, Propylene Glycol, Edetate Disodium
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
NDC: 82199-610-26 7.7ml in 1 Vial
7.7ml Label (7.7ml)
* Please review the disclaimer below.
