Label: RADX- lidocaine lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated July 30, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!