FDA.reportPublic FDA data

REGENECARE HA GEL

Manufacturer
BIOMED LABORATORIES
Effective date
2023-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:34:45

Label at a glance#

ProductREGENECARE HA
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns • sunburns • 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

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 • sunburns • minor cuts • scrapes • insect bites • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

  • If swallowed, get medical help or contact 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 a doctor
  • Do not use in large quantities, particularly over raw surfaces or blistered areas

Warning section

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

OTHER SAFETY INFORMATION

Store at room temperature

Avoid freezing and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

Manufactured For:

MPM Medical

Mesquite, TX 75149

www.mpmmed.com • 800.232.5512

TUBE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85G TUBE85G TUBE14G TUBE14G TUBE

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72846-56072846-560-01, 72846-560-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

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
f4ec9341-b80a-37fc-e053-2a95a90a0974f4ec9341-b809-37fc-e053-2a95a90a09742023-02-17WarningsExact identifier
spl id: f4ec9341-b80a-37fc-e053-2a95a90a0974
spl set id: f4ec9341-b809-37fc-e053-2a95a90a0974

Reported adverse events (FAERS/openFDA)#

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