REGENECARE HA- lidocaine hcl gel

REGENECARE HA by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 2%

Purpose

Anesthetic

Uses

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 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

INGREDIENTS AND APPEARANCE

REGENECARE HA 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66977-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	20 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66977-107-03	85 g in 1 TUBE
2	NDC: 66977-107-25	4 g in 1 TUBE

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

Labeler - MPM Medical, Inc. (119643406)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories, LLC		055329696	manufacture(66977-107)