REGENECARE HA- lidocaine hcl gel 
MPM Medical LLC

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.

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MP00107 (Hydrogel) MPM Regenecare HA Gel 3oz. - label correction

Active Ingredient

Lidocaine HCl 2%

Purpose

Anesthetic

Uses

For the temporary relief of pain and itching associated with

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

MP00107 MPM Regenecare HA Gel 3oz

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
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
CARBOMER 940 (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; Type 0: Not a Combination Product01/05/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/05/2007
Labeler - MPM Medical LLC (081241522)

Revised: 3/2022
Document Id: da2f99ba-2550-41a7-e053-2a95a90ab74f
Set id: c3eec066-38e8-4617-b34d-2f72ffb7a324
Version: 5
Effective Time: 20220314
 
MPM Medical LLC