Lidocaine 5% Anorectal Cream

Lidocaine 5% Anorectal Cream
SPL v2
SPL
SPL Set ID 456d41fe-8449-4980-9291-d7a3b65a900d
Route
RECTAL
Published
Effective Date 2024-11-13
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 (allyl Pentaerythritol Crosslinked) Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Drug Facts

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Drug Facts

Uses

Temporarily relieves pain and itching due to anorectal disorders

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

When using this product

  • Avoid contact with eyes
  • Do not exceed recommended dosage unless directed by a doctor
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 externally to the affected area up to 6 times a day.
  • Children under 12 years of age: Consult a doctor
Questions?

Call 800-936-3088

Active Ingredient

Lidocaine 5% w/w

Other Information
  • Store at room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients

Benzyl Alcohol, Carbomer, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate

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
Principal Display Panel 30 Gram Tube Carton

NDC 39328-025-30

Lidocaine

5%

Anorectal Cream

PATRIN

PHARMA

Net Wt. 30 grams


Structured Label Content

Uses

Temporarily relieves pain and itching due to anorectal disorders

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Local anesthetic

Warnings

When using this product

  • Avoid contact with eyes
  • Do not exceed recommended dosage unless directed by a doctor
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 externally to the affected area up to 6 times a day.
  • Children under 12 years of age: Consult a doctor
Questions?

Call 800-936-3088

Active Ingredient

Lidocaine 5% w/w

Other Information (Other information)
  • Store at room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbomer, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate

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
Principal Display Panel 30 Gram Tube Carton (PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton)

NDC 39328-025-30

Lidocaine

5%

Anorectal Cream

PATRIN

PHARMA

Net Wt. 30 grams


Advanced Ingredient Data


Raw Label Data

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