372fe018-1e5a-9ec4-e063-6294a90a1500

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

Purpose

Topical anesthetic

Description

LIDOCAINE 5%


Medication Information

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.
Uses

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

Purpose

Topical anesthetic

Other Information

Store between 15°-30° C (59°-30° F).

Description

LIDOCAINE 5%

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

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%

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

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.
Uses (USES)

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

Purpose (PURPOSE)

Topical anesthetic

Other Information (OTHER INFORMATION)

Store between 15°-30° C (59°-30° F).

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

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%

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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