Label: DERMARAD RELIEF POST RADIATION CALMING- lidocaine 3 percent liquid

  • NDC Code(s): 76348-970-01, 76348-970-50
  • Packager: Renu Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 8, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine 3%

  • PURPOSE

    Purpose

    External Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves pain and itching due to

    • sunburn
    • minor burns
    • minor cuts
    • minor skin irritations
  • WARNINGS

    Warnings

    For external use only

  • STOP USE

    Stop use and ask a doctor if

    • Condition gets worse
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again in a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed - get medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years and older apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age : ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Cyclopentasiloxane, Dihydroeugenol, Dimethicone, Dimethiconol, Dimethicone/Vinyl Dimethicone Crosspolymer, Helianthus Annuus (Sunflower) Seed Oil, Isoeugenyl Acetate, Petrolatum, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.

  • OTHER SAFETY INFORMATION

    Manufactured in the U.S.A. for Dermamedics, LLC

    Oklahoma City, OK 73112

    www.dermamedics.com

    1 800 990 6552

  • STATEMENT OF IDENTITY

    DERMAMEDICS

    Post Radiation

    Calming

    Serum with

    3 % Lidocaine

  • WHEN USING

    When using this product

    Do not use in large quantities particularly over raw surfaces or blistered areas

    Avoid contact with the eyes

  • PRINCIPAL DISPLAY PANEL

    PRODUCT BOX FOR POST RADIATION CALMING SERUM

    product box

    PRODUCT ARTWORK

    PACKAGE ART

  • INGREDIENTS AND APPEARANCE
    DERMARAD RELIEF POST RADIATION CALMING 
    lidocaine 3 percent liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ISOEUGENYL ACETATE (UNII: 9DF21GI8W6)  
    SQUALANE (UNII: GW89575KF9)  
    DIHYDROEUGENOL (UNII: A3XE712277)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-970-011 in 1 BOX08/08/2022
    1NDC:76348-970-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01508/08/2022
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-970)
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