LMX4 by Ferndale Laboratories, Inc. LMX4- lidocaine cream

LMX4 by

Drug Labeling and Warnings

LMX4 by is a Otc medication manufactured, distributed, or labeled by Ferndale Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

• minor cuts
• minor scrapes
• minor burns
• sunburn
• minor skin irritations
• insect bites
  

Warnings

For external use only.

Do not use

• in or near the eyes
• in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if:

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

Keep out of reach of children.

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

Directions

• Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
• Children under 2 years: Consult a doctor

Other Information

• May be applied under occlusive dressing.

• 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, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, trolamine, vitamin E acetate, water

Package Labels-Principal Display Panels

Manufactured by Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll free (888) 548-0900
www.ferndalelabs.com

L.M.X.4® is a registered trademark of Ferndale IP, Inc.
Tegaderm™ is a trademark of 3M Corporation.

NDC: 0496-0882-06 L.M.X.4® 5 x 5 grams

NDC: 0496-0882-07 L.M.X.4® 5 x 5 grams with 10 3M Tegaderm™ Transparent Dressings

NDC: 0496-0882-15 L.M.X.4® 15 grams

NDC: 0496-0882-30 L.M.X.4® 30 grams

NDC: 0496-0882-71 L.M.X.4® 30 grams with 10 3M Tegaderm™ Transparent Dressings

INGREDIENTS AND APPEARANCE

LMX4 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0496-0882
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0496-0882-06	5 in 1 CARTON	01/03/2011
1	NDC: 0496-0882-05	5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0496-0882-07	5 in 1 BOX	01/03/2011
2	NDC: 0496-0882-05	5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0496-0882-15	15 g in 1 TUBE; Type 0: Not a Combination Product	01/03/2011
4	NDC: 0496-0882-30	30 g in 1 TUBE; Type 0: Not a Combination Product	01/03/2011
5	NDC: 0496-0882-05	5 g in 1 TUBE; Type 0: Not a Combination Product	01/03/2011
6	NDC: 0496-0882-71	1 in 1 BOX	01/03/2011
6	NDC: 0496-0882-30	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/03/2011

Labeler - Ferndale Laboratories, Inc. (005320536)

Establishment
Name	Address	ID/FEI	Business Operations
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0882)