Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID c2c0cb17-401a-4ba2-aa04-64c9b43cd21b
Route
TOPICAL
Published
Effective Date 2020-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.5 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 2019-05-29

Description

Lidocaine 5% w/w

Purpose

Anorectal (Hemorrhoidal)


Medication Information

Purpose

Anorectal (Hemorrhoidal)

Description

Lidocaine 5% w/w

Uses

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

Warnings

For external use only

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 2 years: Consult a doctor

Active Ingredient

Lidocaine 5% w/w

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

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water.

Questions Or Comments

Contact our dedicated Customer Care at +1(877) 786 2001 or email us at [email protected]

Principal Display Panel

NDC 69903-004-10

Dr. Numb®

Lidocaine Cream

RAPID ABSORPTION!

Maximum Strength Pain Reliever

10g

When Using This Product
  • do not exceed the recommeded daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicators
Keep Out of Reach of Children

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

Stop the Use and Consult 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

Structured Label Content

Uses

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

Purpose

Anorectal (Hemorrhoidal)

Warnings

For external use only

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 2 years: Consult a doctor

Active Ingredient (Active ingredient)

Lidocaine 5% w/w

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

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water.

Questions Or Comments (Questions or Comments)

Contact our dedicated Customer Care at +1(877) 786 2001 or email us at [email protected]

Principal Display Panel

NDC 69903-004-10

Dr. Numb®

Lidocaine Cream

RAPID ABSORPTION!

Maximum Strength Pain Reliever

10g

When Using This Product (When using this product)
  • do not exceed the recommeded daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicators
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

Stop the Use and Consult Doctor If (Stop the use and consult 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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)