Active Ingredients
Benzalkonium chloride 0.13%
Lidocaine hydrochloride 0.5%
Refill 3 Cream
FDA Label NDC 50814-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gfa Production (xiamen) Co., Ltd. for the product Refill 3 (NDC 50814-017). 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 reah of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid antiseptic
Pain relieving cream
Uses
- First aid to help prevent infection in minor cuts, scrapes, and burns.
- For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Warnings
For external use only.
Do Not Use
• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor
Ask A Doctor Before Use If You Have
• deep or puncture wounds • animal bites • serious burns.
Stop Use And Ask A Doctor If
• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reah Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
- Children under 2 years of age: consult a doctor
- May be covered with a sterile bandage
Other Information
Store at room temperature
Inactive Ingredients
glycerin monostearate, glycerol, purified water
* Please review the disclaimer below.
