LMX4- lidocaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Ferndale Laboratories, Inc.

INN (International Name):

LIDOCAINE

Composition:

LIDOCAINE 40 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical anesthetic temporarily relieves pain and itching due to - minor cuts - minor scrapes - minor burns - sunburn - minor skin irritations - insect bites

Authorization status:

OTC monograph not final

Summary of Product characteristics

LMX4- LIDOCAINE CREAM
FERNDALE LABORATORIES, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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L.M.X.4
ACTIVE INGREDIENT
Lidocaine 4% w/w
PURPOS E
Topical anesthetic
US ES
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 [phone]
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
NDC 0496-0882-05 L.M.X.4 5 grams
LMX4
lidocaine cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN O