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NDC 66977-0117-04 REGENECARE HA 20 mg/mL Details

REGENECARE HA 20 mg/mL

REGENECARE HA is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by MPM Medical LLC. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	66977-0117
Product ID	66977-117_da2f43a6-af79-4fbc-e053-2a95a90a2029
Associated GPIs	90850060100916
GCN Sequence Number	070657
GCN Sequence Number Description	lidocaine/hyaluronic/collagen SPRY GL ML 2 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	34267
HICL Sequence Number	035037
HICL Sequence Number Description	LIDOCAINE HCL/HYALURONIC ACID/ALOE VERA/COLLAGEN
Brand/Generic	Brand
Proprietary Name	REGENECARE HA
Proprietary Name Suffix	n/a
Non-Proprietary Name	lidocaine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	MPM Medical LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 66977-0117-04 (66977011704)

Pricing Information	N/A
NDC Package Code	66977-117-04
Billing NDC	66977011704
Package	120 mL in 1 BOTTLE (66977-117-04)
Marketing Start Date	2009-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0eee554f-dfe0-433a-9665-8bdb95229888 Details

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 barbadensis leaf extract, Benzethonium chloride, Carbomer, Glycerin, Iodopropynyl butylcarbamate, 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:66977-117
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66977-117-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2009

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

Labeler - MPM Medical LLC (081241522)

Revised: 3/2022

Document Id: da2f43a6-af79-4fbc-e053-2a95a90a2029

Set id: 0eee554f-dfe0-433a-9665-8bdb95229888

Version: 2

Effective Time: 20220314