Drug Facts
Drug Facts (Box Wound Care Lines 20190430)
Recelltis
FDA Label NDC 71929-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cellnovation Technology for the product Recelltis (NDC 71929-070). 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 (in each gram), uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Gram)
Bacitracin Zin 400 units
Neomycin Sulfate 5mg
Polymyxin B Sulfate 5,000 units
Lidocaine Hydrochloride 20mg
Uses
Helps prevent infection and helps promote skin repair:
- Cuts
- Scrapes
- Burns
- Bed Sores
- Pressure Ulcers
- Diabetic Wounds
- Road Rash
Warnings
For external use only
Do Not Use
- In the eyes
- Over large areas of the body
Ask A Doctor Before Use If You Have
- Any allergies to the ingredients
Stop Use And Ask A Doctor If
- condition persists or gets worse
- rash or other allergic reaction develops
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- clean the affected area
- apply a small amount (thin layer) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Other Information
- store at 10° to 32C (50° to 90°F)
- protect from freezing and avoid excessive heat
Inactive Ingredients
Carboxymethyl Cellulose, Cetostearyl Alcohol, Cetyl Alcohol, Coenzyme Q-10, Purified Water, Phenoxyethanol, Polysorbate 80, Sorbitan Oleate, Tocopheryl Acetate, White Petrolatum, Zinc Gluconate
* Please review the disclaimer below.
