Otc - Active Ingredient
Active Ingredients
Allantoin 1%
Lidocaine 4%
Dermarad Relief Emulsion
FDA Label NDC 76348-720
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 (NDC 76348-720). 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, warnings, otc - do not use, otc - purpose, otc - questions, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Warnings
For External Use Only
Avoid contact with the eyes.
If condition worsens or if symptoms last more than
7 days or clear up and occur again within a few days,
discontinue use and consult a physician. Do not use on:
- Deep or puncture wounds
- Animal bites
- Serious burns
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Do Not Use
Do not use on:
- Deep or puncture wounds
- Animal bites
- Serious burns
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Purpose
Purpose
Skin Protectant
Topical Analgesic
Otc - Questions
DermaMedics LLC, Oklahoma City, OK 73104
www.dermamedics.com
1-800-990-6552
Dosage & Administration
Directions: Adults and children 2 years of age and older,
apply to affected areas no more than 3 to 4 times daily.
For children under 2 years of age, consult your physician.
Indications & Usage
Uses
- For the temporary relief of pain and itching associated with minor burns, sunburn, or minor skin irritations.
- Temporarily protects minor burns.
- Temporarily protects and helps relieve chapped or cracked skin.
Inactive Ingredient
Inactive Ingredients:
Capric/Caprylic Triglyceride, Capryl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Deionized Water, Dihydroeugenol,
Dimethicone, Dimethyl Isosorbide, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Stearate, Hexylene Glycol, Hydroxypropyl Starch Phosphate, Isoeugenyl Acetate, Niacinamide, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Polyacrylate
Crosspolymer-6, PPG/SMDI Copolymer, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium PCA, Squalane, Stearic Acid, Tocopherol.
Statement Of Identity
DermaRad Relief
Topical Rehydrating Emulsion
Otc - Keep Out Of Reach Of Children
BOX SHOWS KEEP OUT OF REACH OF CHILDREN STATEMENT
Product Tube Image And Product Box Image
PRODUCT TUBE AND PRODUCT BOX
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