REGENECARE HA by BIOMED LABORATORIES REGENECARE HA GEL

REGENECARE HA by

Drug Labeling and Warnings

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

Drug Details [pdf]

REGENECARE HA- lidocaine hydrochloride gel 
BIOMED LABORATORIES

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 GEL

Active ingredient

Lidocaine HCl 2%

Purpose

Anesthetic

Uses

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

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

Questions

Manufactured For:

MPM Medical

Mesquite, TX 75149

www.mpmmed.com 800.232.5512

TUBE LABEL

REGENECARE HA 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72846-560
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 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72846-560-01	85 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2007
2	NDC: 72846-560-02	14 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/05/2007

Labeler - BIOMED LABORATORIES (055329696)

Establishment
Name	Address	ID/FEI	Business Operations
BIOMED LABORATORIES		055329696	manufacture(72846-560)

Revised: 2/2023

Document Id: f4ec9341-b80a-37fc-e053-2a95a90a0974

34390-5

Set id: f4ec9341-b809-37fc-e053-2a95a90a0974

Version: 1

Effective Time: 20230217