RADX- lidocaine lotion
Cosmetic Specialty Labs, 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.

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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.

keep out of eyes. Rinse with water to remove.

Stop us and ask a doctor if rash occurs.

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

RADX
lidocaine lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
.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)

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

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

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

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