SPL v1
SPL
SPL Set ID 372fe018-1e5a-9ec4-e063-6294a90a1500
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Propylparaben Cetostearyl Alcohol Ceteareth-12 Trolamine Propylene Glycol Methylparaben Edetate Disodium Water Mineral Oil .alpha.-tocopherol Stearic Acid Sodium Cetostearyl Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

LIDOCAINE 5%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

LIDOCAINE 5%

Uses

helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders.

Section 51727-6

water. stearic acid, vitamin E, EDTA, cetostearyl alcohol, sodium cetostearyl sulfate, trolamine, methylparaben, mineral oil, propylene glycol, propyl paraben

Section 51945-4

Section 53413-1

TELEPHONE NUMBER : 248 325 4231

Warnings
  • use only as directed.
  • Avoid contact with eyes.
  • do not exceed recommended dosage unless directed by a doctor.
  • do not out this product into the rectum by using fingers or any mechanical device or applicator.
Directions:
  • Adult and children 12 years and over:

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. apply externally to the affected area up to 6 times a day

  • children under 12 years of age: consult a doctor.
Active Ingredient

LIDOCAINE 5%

Other Information

Store between 15°-30° C (59°-30° F).

Keep Out of Reach of Children

keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Using and Ask A Doctor If:
  • rectal bleeding occurs.
  • condition worsens or does not improve within 7 days.
  • symptoms clear up and occur again within a few days.
  • an allergic reaction develops to ingredients in this product.
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
  • If pregnant or breast-feeding,ask a health professional before use.

Structured Label Content

Uses (USES)

helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders.

Section 51727-6 (51727-6)

water. stearic acid, vitamin E, EDTA, cetostearyl alcohol, sodium cetostearyl sulfate, trolamine, methylparaben, mineral oil, propylene glycol, propyl paraben

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

TELEPHONE NUMBER : 248 325 4231

Purpose (PURPOSE)

Topical anesthetic

Warnings (WARNINGS)
  • use only as directed.
  • Avoid contact with eyes.
  • do not exceed recommended dosage unless directed by a doctor.
  • do not out this product into the rectum by using fingers or any mechanical device or applicator.
Directions: (DIRECTIONS:)
  • Adult and children 12 years and over:

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. apply externally to the affected area up to 6 times a day

  • children under 12 years of age: consult a doctor.
Active Ingredient (ACTIVE INGREDIENT)

LIDOCAINE 5%

Other Information (OTHER INFORMATION)

Store between 15°-30° C (59°-30° F).

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Using and Ask A Doctor If: (STOP USING AND ASK A DOCTOR IF:)
  • rectal bleeding occurs.
  • condition worsens or does not improve within 7 days.
  • symptoms clear up and occur again within a few days.
  • an allergic reaction develops to ingredients in this product.
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
  • If pregnant or breast-feeding,ask a health professional before use.

Advanced Ingredient Data


Raw Label Data

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