Active Ingredients
Benzalkonium Chloride 0.13% .................Topical Antiseptic
Lidocaine Hydrochloride 0.5% .................Topical Analgesic
Diabetic First Aid Gel Professional
FDA Label NDC 71521-393
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lavior Inc. for the product Diabetic First Aid Gel Professional (NDC 71521-393). 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, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Antiseptic
Topical Analgesic
Uses
First aid to help prevent infection in minor:
■cuts ■scrapes ■burns
Temporarily relieves pain and itching associated with:
■minor burns ■cuts ■scrapes ■insect bites ■minor skin irritations
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
- animal bites
- serious burns
Stop Use And Ask A Doctor If
- condition or symptoms get worse or last more than 1 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 Center right away.
Directions
Adults and children 12 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
- if bandaged, let dry first
Children under 12 years of age: consult a doctor
Other Information
Store at room temperature
Inactive Ingredients
Water, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice, Xanthan Gum, Phenoxyethanol, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Gluconolactone, Polyvinyl Alcohol, Alcohol, Citric Acid, Sodium Benzoate, Potassium Sorbate
Questions?
Call toll free 1-844-474-2552 or visit www.lavior.com
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