Lidocaine 5%

Lidocaine 5%
SPL v2
SPL
SPL Set ID 32964ec3-1880-477b-9f71-2222c39106aa
Route
TOPICAL
Published
Effective Date 2025-01-23
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Hydrogenated Soybean Lecithin Benzyl Alcohol Polysorbate 80 Triethanolamine .alpha.-tocopherol Acetate Carbomer 940 Isopropyl Myristate Propylene Glycol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-05

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.

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 applying.
  • 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.
Questions?

1-877-977-0687

Other Information

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Active Ingredient 

Lidocaine 5% w/w

Inactive Ingredients

Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E- Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water   

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 mechanical device or applicator
Keep Out of Reach of Children.

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

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
Principal Display Panel 30 G Tube Carton

NDC 75834-333-30



Lidocaine 5%



Topical Anesthetic Cream-Anorectal




NIVAGEN



net wt. 30 g (1 oz)
 







 


Structured Label Content

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

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 applying.
  • 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.
Questions?

1-877-977-0687

Other Information

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Active Ingredient 

Lidocaine 5% w/w

Inactive Ingredients

Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E- Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water   

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 mechanical device or applicator
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 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
Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

NDC 75834-333-30



Lidocaine 5%



Topical Anesthetic Cream-Anorectal




NIVAGEN



net wt. 30 g (1 oz)
 







 


Advanced Ingredient Data


Raw Label Data

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