Lidonumb

Lidonumb
SPL v1
SPL
SPL Set ID e7569ceb-6e4d-4417-9e61-ab86fc7e05c6
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.05 g)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Propylene Glycol Triethanolamine .alpha.-tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-18

Description

Lidocaine 5% w/w

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 5% w/w

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Section 51945-4

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. lic. No.: G/25/1362

Issued: 12/2025

Warnings

For external use only.

Directions
  • 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 soft cloth before application of this product.
  • 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.
Drug Facts

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 940, hydrolysed soy lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E acetate, water

Questions Or Comments?

Call 1-844-474-7464

When Using This Product
  • avoid contact with eyes
  • do not use in large quantities, particularly over large surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechnical device or applicator.
Stop Use and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop 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 the pain and itching due to anorectal disorders.

Section 51945-4 (51945-4)

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. lic. No.: G/25/1362

Issued: 12/2025

Purpose

Topical anesthetic

Warnings

For external use only.

Directions
  • 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 soft cloth before application of this product.
  • 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.
Drug Facts

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 940, hydrolysed soy lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E acetate, water

Questions Or Comments? (Questions or comments?)

Call 1-844-474-7464

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use in large quantities, particularly over large surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechnical device or applicator.
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 to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop 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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