RadX

Manufacturer: Cosmetic Specialty Labs, Inc.
Effective date: 2021-07-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:41:45

Label at a glance#

ProductRadX

Active ingredientLIDOCAINE

Label structure10 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Incredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 2%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop us and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2565921	lidocaine 2 % Topical Lotion	PSN	1
2565921	lidocaine 20 MG/ML Topical Lotion	SCD	1
2565921	lidocaine 2 % Topical Lotion	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-650-33	2024-01-30	C162847	48780-1	1030e365-62af-111a-e063-dadaa90a10e2	c85c8aa3-973f-4b2f-e053-2995a90a404c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58133-650-33	RadX	100 mL in 1 TUBE	LOTION	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-650	RADX (LIDOCAINE) LOTION [COSMETIC SPECIALTY LABS, INC.]	1	Legacy NDC, 1 package rows	20210803_c85c8aa3-973f-4b2f-e053-2995a90a404c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

RadX
Lidocaine
.ALPHA.-TOCOPHEROL LINOLEATE, D-
XANTHAN GUM
ALOE VERA LEAF
SILK, ACID HYDROLYZED (1000 MW)
ALLANTOIN
ALKYL (C12-15) BENZOATE
PAPAYA
CETOSTEARYL ALCOHOL
SUNFLOWER OIL
ETHYLHEXYL OLEATE
CETEARYL OLIVATE
CETYL PHOSPHATE
COCONUT OIL
HIPPOPHAE RHAMNOIDES FRUIT OIL
HYDROGENATED OLIVE OIL UNSAPONIFIABLES
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85)
FRUIT BROMELAIN
WATER
HYALURONATE SODIUM
SORBITAN OLIVATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58133-650	58133-650-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
.ALPHA.-TOCOPHEROL LINOLEATE, D-	G0N132Q0ED	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
SILK, ACID HYDROLYZED (1000 MW)	8549W658QV	IACT
ALLANTOIN	344S277G0Z	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
PAPAYA	KU94FIY6JB	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
ETHYLHEXYL OLEATE	R34927QY59	IACT
CETEARYL OLIVATE	58B69Q84JO	IACT
CETYL PHOSPHATE	VT07D6X67O	IACT
COCONUT OIL	Q9L0O73W7L	IACT
HIPPOPHAE RHAMNOIDES FRUIT OIL	TA4JCF9S1J	IACT
HYDROGENATED OLIVE OIL UNSAPONIFIABLES	B8MIX97W95	IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE	D2QHA03458	IACT
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85)	2YGO1190AP	IACT
LIDOCAINE	98PI200987	ACTIB
FRUIT BROMELAIN	F0ZCA6O9QT	IACT
WATER	059QF0KO0R	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
SORBITAN OLIVATE	MDL271E3GR	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c85c8aa3-9740-4b2f-e053-2995a90a404c			c85c8aa3-973f-4b2f-e053-2995a90a404c	2021-07-30	Warnings	Exact identifier spl id: c85c8aa3-9740-4b2f-e053-2995a90a404c spl set id: c85c8aa3-973f-4b2f-e053-2995a90a404c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.