Lmx5 (lidocaine 5%) Anorectal Cream

Lmx5 (lidocaine 5%) Anorectal Cream
SPL v5
SPL
SPL Set ID 34f8ed6b-4a52-4a99-9c1b-254196dc29b0
Route
TOPICAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C Cholesterol Lecithin, Soybean Isopropyl Myristate Polysorbate 80 Propylene Glycol Water Trolamine Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-10-01

Description

Lidocaine 5% w/w

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Lidocaine 5% w/w

Uses

temporarily relieves pain and itching due to anorectal disorders

Warnings


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.

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

Active Ingredient

Lidocaine 5% w/w

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 homopolymer, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

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.


Structured Label Content

Uses

temporarily relieves pain and itching due to anorectal disorders

Purpose

Local anesthetic

Warnings


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.

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

Active Ingredient (Active ingredient)

Lidocaine 5% w/w

Other Information (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 homopolymer, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

When Using This Product (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 (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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