Niv40- Lidocaine Numbing Cream

Niv40- Lidocaine Numbing Cream
SPL v2
SPL
SPL Set ID 1319ee69-8b3f-5815-e063-6294a90a5ad5
Route
TOPICAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Cholesterol Isopropyl Myristate Alpha-tocopherol Acetate Benzyl Alcohol Lecithin, Soybean Trolamine Propylene Glycol Water Polysorbate 80 Carbomer 940

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-07

Description

Lidocaine 5%

Purpose

External Analgesic


Medication Information

Warnings and Precautions

For external use only

Purpose

External Analgesic

Dosage and Administration

Local anesthetic

Description

Lidocaine 5%

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Section 51727-6

Inactive Ingredients: Benzyl alcohol, carbomer, C10-18 triglycerides, cetearyl alcohol, glycel stearate, glycine soja (soybean) oil, isopropyl myristate, PEG-100 stearate, propylene glycol, stearic acid, tocopherol, triethanolamine, water (aqua)

Section 51945-4

Questions

call toll free 866-933-6337

Active Ingredient

Lidocaine 5%

When Using This Product

Avoid contact with eyes. Do not use in large quantities, particularly over large surfaces or blistared areas. Do no exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical 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.

Dosage and Administration (34068-7)

Local anesthetic

Warnings and Precautions (34071-1)

For external use only

Section 51727-6 (51727-6)

Inactive Ingredients: Benzyl alcohol, carbomer, C10-18 triglycerides, cetearyl alcohol, glycel stearate, glycine soja (soybean) oil, isopropyl myristate, PEG-100 stearate, propylene glycol, stearic acid, tocopherol, triethanolamine, water (aqua)

Section 51945-4 (51945-4)

Purpose

External Analgesic

Questions

call toll free 866-933-6337

Active Ingredient

Lidocaine 5%

When Using This Product (When using this product)

Avoid contact with eyes. Do not use in large quantities, particularly over large surfaces or blistared areas. Do no exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical 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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