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LMX5

Ferndale Laboratories, Inc.

LMX5 (lidocaine 5%) Anorectal Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

LMX5 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.

LMX5 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

Back Panel

LMX5

Front Panel

LMX5

LMX5

lidocaine CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0496-0883
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LIDOCAINE LIDOCAINE 50 mg

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
CARBOMER HOMOPOLYMER TYPE C
CHOLESTEROL
LECITHIN, SOYBEAN
ISOPROPYL MYRISTATE
polysorbate 80
propylene glycol
water
TROLAMINE
ALPHA-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0496-0883-30 30 in 1 TUBE
2 NDC:0496-0883-15 15 in 1 TUBE
3 NDC:0496-0883-97 1 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2003-10-01


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Be sure to consult your doctor before taking any medication!
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