RadX by Cosmetic Specialty Labs, Inc. RADX- lidocaine lotion

RadX by

Drug Labeling and Warnings

RadX by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Incredients

Lidocaine 2%

Purpose

Topical Anesthetic

Uses

• Provides immediate pain relief to skin undergoing radiation therapy
• Helps reduce inflammation
• Hydrates skin into the 2nd and 3rd dermal layers
• Helps Promote cell regeneration

Warnings

For external use only.

WHEN USING

keep out of eyes. Rinse with water to remove.

STOP USE

Stop us and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep ouf of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply immediately following treatments, increasing to multiple times daily if skin becomes irritated, painful or inflamed.
• May be applied as frequently as once per hour.

Inactive Ingredients

Water, Cetearyl Olivate, Sorbitan Olivate, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Cetyl Phosphate, Cetearyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Hippophae Rhamnoides (Sea Buckthorn) Extract, Hydrogenated Ethylhelxyl Olivate, Hydrogenated Olive Oil Unsaponifiables, Carica Papaya (Papaya) Seed Oil, Beta-Glucan, C12-C15 Alkyl Benzoate, Tocopheryl Linoleate/Oleate, Sodium Hyaluronate, Allentoin, Aloe Barbadensis, Bromelain, Xanthan Gum, Hydrolyzed Silk

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RADX 
lidocaine lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)
ALLANTOIN (UNII: 344S277G0Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PAPAYA (UNII: KU94FIY6JB)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ETHYLHEXYL OLEATE (UNII: R34927QY59)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL PHOSPHATE (UNII: VT07D6X67O)
COCONUT OIL (UNII: Q9L0O73W7L)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
FRUIT BROMELAIN (UNII: F0ZCA6O9QT)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SORBITAN OLIVATE (UNII: MDL271E3GR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-650-33	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/30/2021

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-650) , label(58133-650) , pack(58133-650)