Label: MYDERM NUMBING ROLL-ON- inspec solutions llc cream

  • 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 January 2, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine HCI 5%

  • PURPOSE

    Uses Helps relieve anorectal symptoms (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

  • WARNINGS

    Warnings For external use only

  • WHEN USING

    When using this product • avoid contact with the eyes or mucous membranes.

  • STOP USE

    Stop use and ask doctor if • condition worsens, or if symptoms persist for more than 7 days, or dear up and reoccur again within a few days. Do not use if pregnant or breast-feeding.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • PREGNANCY

    Do not use if pregnant or breast-feeding.

  • INDICATIONS & USAGE

    Directions • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2

  • INACTIVE INGREDIENT

    Inactive Ingredients Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol,

    C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl

    Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl

    Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl

    Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21 , Water.

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    myDerm Numbing Roll-on 5% Lidocaine

  • INGREDIENTS AND APPEARANCE
    MYDERM NUMBING ROLL-ON 
    inspec solutions llc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-058-0189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/02/2023
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-058)
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