Radiaguard Advanced Radiation Relief Lotion
FDA Label NDC 81034-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smooth Side, Inc for the product Radiaguard Advanced Radiation Relief (NDC 81034-103). 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, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine HCl 1.00%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of pain (and itching) associated with minor burns, sunburns, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings

For external use only.

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas.

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.

Other Inforamtion:

  • Store at 20-25°C (68-77°F) and protect from moisture.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Calendula Officinals Extract, Camellia Sineisis (Green Tea) Extract, Carbomer, Cetyl Alcohol, Ethylhexylglyerin, Glycerin, Glyceryl Stearate, Glycol Stearate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Phenoxyethanol, Polysorbate-80, Prunus Amygdalus Dulcis (Almond) Oil, Simmondsia Chinesis (Jojoba) Oil, Stearic Acid, Triethanolamine.

Questions?

888.371.4615

  • www.radiaguard.com

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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