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

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-650-33100 mL in 1 TUBE; Type 0: Not a Combination Product07/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/30/2021
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-650) , label(58133-650) , pack(58133-650)

Revised: 7/2021
Document Id: c85c8aa3-9740-4b2f-e053-2995a90a404c
Set id: c85c8aa3-973f-4b2f-e053-2995a90a404c
Version: 1
Effective Time: 20210730
 
Cosmetic Specialty Labs, Inc.