Active Ingredient
Banzalkonium Chloride 0.13%
Lidocaine Chloride 0.5%
Aloe 0.02%
Roosin Burn
FDA Label NDC 81552-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roosin Medical Co., Ltd for the product Roosin Burn (NDC 81552-002). 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, otc - do not use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antiseptic
External Analgesic
Antiseptic and antipyrotic
Use
First aid to help prevent infection and for temporary relief of pain and itching associated with minor cuts scrapes burns
Warnings
For external use only
Otc - Do Not Use
Do not use
- In eyes
- Over large areas of the body
- For more than one week unless directed by a doctor
- If you are allergic to any of the ingredients
- On deep puncture wounds, animal bites, or serious burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away
Directions
Clean affected area
Apply a small amount 1-3 times daily
Children under 2: Consult doctor
Inactive Ingredients
Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water
* Please review the disclaimer below.
