Lidocaine 5%

Lidocaine 5%
SPL v2
SPL
SPL Set ID 78120481-b780-4e41-885d-11e424d1f717
Route
TOPICAL
Published
Effective Date 2016-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Cetyl Alcohol Glyceryl Stearate Se Methylparaben Propylene Glycol Propylparaben Petrolatum White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-04-01

Description

Lidocaine 5% w/w

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Lidocaine 5% w/w

Uses

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings:

For external use only.

Directions
  • When practical, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day.
  • Children under 12 years of age: Consult a doctor
  • To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.
Lidocaine 5%
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

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

When Using This Product
  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop Use and Ask 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 suside or if redness, irritation swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Keep Out of the Reach of Children

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


Structured Label Content

Uses

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Purpose

Local anesthetic

Warnings: (WARNINGS:)

For external use only.

Directions
  • When practical, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day.
  • Children under 12 years of age: Consult a doctor
  • To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.
Lidocaine 5%
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

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop Use and Ask Doctor If (Stop use and ask 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 suside or if redness, irritation swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Keep Out of the Reach of Children (Keep out of the 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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