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NDC 00496-0883-15 LMX5 50 mg/g Details

LMX5 50 mg/g

LMX5 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Ferndale Laboratories, Inc.. The primary component is LIDOCAINE.

Product Information

NDC	00496-0883
Product ID	0496-0883_7974c929-ea52-91a4-e053-2a91aa0a3157
Associated GPIs	89200025003720
GCN Sequence Number	040261
GCN Sequence Number Description	lidocaine CREAM (G) 5 % TOPICAL
HIC3	Q3H
HIC3 Description	HEMORRHOIDALS, LOCAL RECTAL ANESTHETICS
GCN	95404
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Brand
Proprietary Name	LMX5
Proprietary Name Suffix	n/a
Non-Proprietary Name	lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE
Labeler Name	Ferndale Laboratories, Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00496-0883-15 (00496088315)

Pricing Information	N/A
NDC Package Code	0496-0883-15
Billing NDC	00496088315
Package	15 g in 1 TUBE (0496-0883-15)
Marketing Start Date	2003-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 34f8ed6b-4a52-4a99-9c1b-254196dc29b0 Details

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

Warnings

When using this product

avoid contact with eyes
do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs
condition worsens or does not improve within 7 days
allergic reaction occurs
redness, irritation, swelling, pain or other symptoms begin or increase
symptoms clear up and return within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
Adults and Children 12 years and older: Apply to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor.

Other information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol, carbomer 940, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

Package Label

Manufactured for Ferndale Healthcare Inc.

Ferndale, MI 48220 U.S.A.

Toll free (888) 548-0900

www.ferndalehealthcare.com

L.M.X.5® is a registered trademark of Ferndale, IP Inc.

30 gram NDC 0496-0883-30

INGREDIENTS AND APPEARANCE

LMX5

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0496-0883
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0496-0883-30	30 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2003
2	NDC:0496-0883-15	15 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2003
3	NDC:0496-0883-97	1 g in 1 POUCH; Type 0: Not a Combination Product	10/01/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	10/01/2003

Labeler - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0883)

Revised: 10/2018

Document Id: 7974c929-ea52-91a4-e053-2a91aa0a3157

Set id: 34f8ed6b-4a52-4a99-9c1b-254196dc29b0

Version: 3

Effective Time: 20181030