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NDC 76420-0351-30 Eha 4 g/mL Details

Eha 4 g/mL

Eha is a TOPICAL LOTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	76420-0351
Product ID	76420-351_7d77ecf6-5731-d43e-e053-2991aa0af0db
Associated GPIs	90850060004120
GCN Sequence Number	076228
GCN Sequence Number Description	lidocaine HCl LOTION 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	41569
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Brand
Proprietary Name	Eha
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/mL
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Asclemed USA, Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 76420-0351-30 (76420035130)

Pricing Information	N/A
NDC Package Code	76420-351-30
Billing NDC	76420035130
Package	88 mL in 1 BOTTLE (76420-351-30)
Marketing Start Date	2016-06-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 09835640-55c3-4bfa-9ad3-15d37f06e871 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Lidocaine HCI 4%

Purpose

External Anesthetic

Uses

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.

Warning

For external use only.

Avoid contact with eyes

Stop using this product and ask doctor if

symptoms last for more than seven days, or clear up and occur again within a few days
if redness, irritation, swelling, pain or other symptoms increase

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Inactive ingredients

Inactive ingredients: Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, M Polyacrylamide, Steric Acid.

Principal Display Panel - 88 mL Bottle Label

‘Eha Lotion 4%

Pain Relief Lotion

For Professional Use Only

3 OZ (88 mL)

Distributed by

Enovachem ™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

INGREDIENTS AND APPEARANCE

EHA

lidocaine hydrochloride lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:76420-351
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-351-30	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/07/2016

Labeler - Asclemed USA, Inc. (059888437)

Revised: 11/2018

Document Id: 7d77ecf6-5731-d43e-e053-2991aa0af0db

Set id: 09835640-55c3-4bfa-9ad3-15d37f06e871

Version: 2

Effective Time: 20181101