REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]

REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]
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NDC 66977-107-03, 66977-107-25
Set ID c3eec066-38e8-4617-b34d-2f72ffb7a324
Category HUMAN OTC DRUG LABEL
Packager MPM Medical, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active Ingredient

    Lidocaine HCl 2%

  • Purpose

    Anesthetic

  • Uses

    For the temporary relief of pain and itching associated with

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
  • Warnings

    For external use only

    If swallowed, get medical help or contatct a Poison Control Center right away

    Avoid contact with the eyes

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult with a doctor

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

    Keep out of reach of children

  • 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 years of age:  Consult a physician prior to use.

  • Other information

    Store at room temperature

    Avoid freezing and excessive heat

  • Inactive ingredients

    Aloe vera varvadensis leaf extract, Benzethonium chloride, Carbomer, Glycerin, Procollagen, Sodium hyaluronate, Triethanolamine, Water

  • Package Label

    RegeneCareHAFront

    RegeneCareHABack

  • INGREDIENTS AND APPEARANCE
    REGENECARE HA 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66977-107-0385 g in 1 TUBE
    2NDC:66977-107-254 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/05/2007
    Labeler - MPM Medical, Inc. (119643406)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomed Laboratories, LLC055329696manufacture(66977-107)