numbskin maximum strength pain reliever

numbskin maximum strength pain reliever
SPL v1
SPL
SPL Set ID 20c228c8-f2e9-8b8d-e063-6294a90ae327
Route
topical
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
benzyl alcohol carbomer homopolymer, unspecified type lecithin, soybean propylene glycol .alpha.-tocopherol acetate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-28

Purpose

Anorectal (Hemorrhoidal)

Description

Lidocaine 5%


Medication Information

Warnings

For external use only

Uses

For temporary relief of local discomfort, itching, soreness or burning in the perianal area associated with anorectal disorders

Purpose

Anorectal (Hemorrhoidal)

Directions

Adults and children 12 years and older: 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 to the affected area up to 6 times a day.

Children under 12 years: Consult a doctor

Other Information
  • always keep the tube tighlty closed
  • store at temperatures not exceeding 15°C-30°C (59°F - 86°F)
  • protect from freezing
Inactive Ingredients

Benzyl Alcohol, Carbopol, Letcithin, Propylene Glycol, Tocopheryl Acetate, Water

Description

Lidocaine 5%

Principal Display Panel

NDC 69903-007-02

Numbskin Maximum Strength Pain Reliever

Questions?

Contact our dedicated Customer Care at + (877) 786 2001 or email us at [email protected]

Purposes

Anorectal (Hemorrhoidal)

Active Ingredient

Lidocaine 5%

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • condition worsens or does not improve within 7 days
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Uses

For temporary relief of local discomfort, itching, soreness or burning in the perianal area associated with anorectal disorders

Directions

Adults and children 12 years and older: 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 to the affected area up to 6 times a day.

Children under 12 years: Consult a doctor

Other Information (Other information)
  • always keep the tube tighlty closed
  • store at temperatures not exceeding 15°C-30°C (59°F - 86°F)
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbopol, Letcithin, Propylene Glycol, Tocopheryl Acetate, Water

Principal Display Panel

NDC 69903-007-02

Numbskin Maximum Strength Pain Reliever

Questions?

Contact our dedicated Customer Care at + (877) 786 2001 or email us at [email protected]

Purposes

Anorectal (Hemorrhoidal)

Active Ingredient (Active ingredient)

Lidocaine 5%

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put 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)
  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • condition worsens or does not improve within 7 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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