Otc - Active Ingredient
Active Ingredient
Lidocaine 3%
Dermarad Relief Post Radiation Calming Liquid
FDA Label NDC 76348-970
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Dermarad Relief Post Radiation Calming (NDC 76348-970). 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 - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
External Analgesic
Indications & Usage
Uses
Temporarily relieves pain and itching due to
- sunburn
- minor burns
- minor cuts
- minor skin irritations
Warnings
Warnings
For external use only
Otc - Stop Use
Stop use and ask a doctor if
- Condition gets worse
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again in a few days
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
Dosage & Administration
Directions
- adults and children 2 years and older apply to affected area not more than 3 to 4 times daily
- children under 2 years of age : ask a doctor
Inactive Ingredient
Inactive Ingredients:
Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.
Other Safety Information
Manufactured in the U.S.A. for Dermamedics, LLC
Oklahoma City, OK 73112
www.dermamedics.com
1 800 990 6552
Statement Of Identity
DERMAMEDICS
Post Radiation
Calming
Serum with
3 % Lidocaine
Otc - When Using
When using this product
Do not use in large quantities particularly over raw surfaces or blistered areas
Avoid contact with the eyes
Recent Major Changes
No changes at all to section. We have cloned submission for a second product with another NDC Code.
No changes to any section except Principal Package display and NDC #
Package Label.Principal Display Panel
PRODUCT BOX FOR POST RADIATION CALMING SERUM
PRODUCT ARTWORK
* Please review the disclaimer below.
