FDA.reportPublic FDA data

REGENECARE HA

Manufacturer
MPM Medical LLC
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:09

Label at a glance#

ProductREGENECARE HA
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations

Dosage and administration

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.

Storage and handling

Store at room temperature. Avoid freezing and excessive heat.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2%

Purpose

OTC - PURPOSE SECTION

Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature.

Avoid freezing and excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera barbadensis leaf extract, Benzethonium chloride, Carbomer, Glycerin, Iodopropynyl butylcarbamate, Procollagen, Sodium hyaluronate, Triethanolamine, Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle labelBottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN4
1012594REGENECARE HA 2 % Topical Spray HydrogelPSN4
1012594lidocaine hydrochloride 20 MG/ML Topical Spray [Regenecare]SBD4
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD4
1010769lidocaine hydrochloride 2 % Topical SpraySY4
1012594Regenecare 0.02 MG/MG Topical Spray GelSY4
1012594Regenecare 2 % Topical Spray GelSY4
1012594Regenecare 20 MG/ML Topical SpraySY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130366977117043GTIN-13: 0366977117043
EAN-13: 0366977117043
GTIN-12: 366977117043
UPC-A: 366977117043
GTIN storage (14 digits): 00366977117043		Regenecare HA Spray label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66977-117-042024-05-17C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.
66977-117-042024-01-30C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.
66977-117-042022-03-16C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.
66977-117-042019-11-27C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66977-117-04REGENECARE HA120 mL in 1 BOTTLEGEL1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66977-117-04ML - Milliliter66977-11726758f4e-e318-4d89-b7a4-86416d9069da12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A1
LIDOCAINEACTIVE MOIETY98PI2009871
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057441
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27E1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66977-11766977-117-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGENECARE HALIDOCAINE HCLMPM Medical LLC0eee554f-dfe0-433a-9665-8bdb952298882026-01-05WarningsExact identifier
ndc (package): 66977-117-04
ndc (product): 66977-117
ndc11 (package): 66977011704
spl id: 47a9559e-2714-c8ff-e063-6294a90ad135
spl set id: 0eee554f-dfe0-433a-9665-8bdb95229888

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.