RadiaGuard Advanced Radiation Relief: Package Insert and Label Information

RADIAGUARD ADVANCED RADIATION RELIEF- lidocaine hydrochloride lotion
SMOOTH SIDE, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
(click image for full-size original)

RADIAGUARD ADVANCED RADIATION RELIEF
lidocaine hydrochloride lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81034-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81034-103-00 113 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/01/2020
Labeler — SMOOTH SIDE, INC (041489180)

Revised: 11/2020 SMOOTH SIDE, INC

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