1. Home
  2. Labeler Index
  3. Ferndale Laboratories, Inc.
  4. 0496-0882
  5. Label Information: Lmx4

FDA Label for Lmx4

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF:
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABELS-PRINCIPAL DISPLAY PANELS

Lmx4 Product Label

The following document was submitted to the FDA by the labeler of this product Ferndale Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

5x5gcarton - 5x5g

5x5gcarton - 5x5g


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




* Please review the disclaimer below.