Active Ingredient
Lidocaine 4% w/w
Lmx4 Cream
FDA Label NDC 0496-0882
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ferndale Laboratories, Inc. for the product Lmx4 (NDC 0496-0882). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if:, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
5x5gcarton (5x5g)
NDC 0496-0882-07 L.M.X.4® 5 x 5 grams with 10 3M Tegaderm™ Transparent Dressings
5x5gwtegadermcarton (5x5gwtegaderm)
NDC 0496-0882-15 L.M.X.4® 15 grams
15gcarton (15g)
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
30gwtegadermcarton (30gwtegaderm)
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