FDA Label for Dermarad Relief Post Radiation Calming
View Indications, Usage & Precautions
Dermarad Relief Post Radiation Calming Product Label
The following document was submitted to the FDA by the labeler of this product Renu Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Lidocaine 3%
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
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