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Radiaguard advanced radiation relief - Medication Information

Product NDC Code 81034-103
Drug Name

Radiaguard advanced radiation relief

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 1543712,
1543717
Application Number M017
Labeler Name SMOOTH SIDE, INC
Packages
Package NDC Code Description
81034-103-00 113 g in 1 tube (81034-103-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Lidocaine HCl 1.00% Purpose Topical Analgesic

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: For the temporary relief of pain (and itching) associated with minor burns, sunburns, minor cuts, scrapes, insect bites, or minor skin irritations.

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
RadiaGuard Advanced Radiation Relief LIDOCAINE HYDROCHLORIDE ALOE VERA LEAF WATER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE GLYCOL STEARATE SUNFLOWER OIL HYALURONIC ACID PHENOXYETHANOL POLYSORBATE 80 ALMOND OIL JOJOBA OIL STEARIC ACID TROLAMINE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Labeling: Bottle

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other inforamtion: Store at 20-25°C (68-77°F) and protect from moisture.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 888.371.4615 www.radiaguard.com

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product Avoid contact with the eyes

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API