Label: REGENECARE HA- lidocaine hcl gel

  • 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 March 14, 2022

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

View All Sections
  • 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 barbadensis leaf extract, Benzethonium chloride, Carbomer, Glycerin, Iodopropynyl butylcarbamate, Procollagen, Sodium hyaluronate, Triethanolamine, Water

  • Package Label

    MP00117 Artwork MPM Regenecare HA Spray 4 fl.oz

  • INGREDIENTS AND APPEARANCE
    REGENECARE HA 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66977-117-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2009
    Labeler - MPM Medical LLC (081241522)
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!