REGENECARE HA by BIOMED LABORATORIES LLC REGENECARE HA SPRAY

REGENECARE HA by

Drug Labeling and Warnings

REGENECARE HA by is a Otc medication manufactured, distributed, or labeled by BIOMED LABORATORIES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REGENECARE HA- lidocaine hcl gel 
BIOMED LABORATORIES 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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REGENECARE HA SPRAY

Active Ingredient

Lidocaine HCl 2%

Purpose

Anesthetic

Use

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 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

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

Questions

Manufactured for:

MPM Medical

Mesquite, TX 75149

www.mpmmed.com 800.232.5512

BOTTLE LABEL

REGENECARE HA 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72846-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72846-550-01	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2009

Labeler - BIOMED LABORATORIES LLC (055329696)

Establishment
Name	Address	ID/FEI	Business Operations
BIOMED LABORATORIES LLC		055329696	manufacture(72846-550)

Revised: 2/2023

Document Id: f4efb4e1-436d-f03d-e053-2995a90a41c6

34390-5

Set id: f4efb4e1-436c-f03d-e053-2995a90a41c6

Version: 1

Effective Time: 20230217