SPL v1
SPL
SPL Set ID f725ecd1-96de-4f9f-94c9-d22c676285b2
Route
TOPICAL
Published
Effective Date 2023-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Glycerin Aloe Shea Butter Retinol Sunflower Oil Glyceryl Stearate Se Pentylene Glycol Cetyl Alcohol Piper Methysticum Whole Peg-100 Stearate .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-07-01

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Uses

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.

Section 51727-6

water, glycerine, Lidocaine Lsopropyl palmitate, Aloe barbadensis leaf juice, Retinol,Helianthus annuus (sunflower)seed oil, Glyceryl stearate,

Pentylene glycol, Butyrospermum parkii (shea)butter,Cetyl alcohol, Piper methysticum leaf/root/stem extract, Peg-100 stearate, Tocopheryl acetate.

Warnings

For external use only

When using this product

  • Do not get into eyes.
  • Do not exceed recommend dosage unless directed by doctor.
  • Do not put this product into rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

  • 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. Do not use if allergic to any ingredients.

If pregnant or breastfeedingask a health professional before use.

Directions
  • When practical clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or bloating 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
  • To use finger cots: roll one finger cot over finger. Gently squeeze cream on to finger cot. Smooth a layer of the cream.
Product Label

Other Information

Store at room temperature. Avoid direct sunlight. Do not use if temper evident packaging has been breached or is missing.

Active Ingredients

Lidocaine 5%


Structured Label Content

Uses

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.

Section 51727-6 (51727-6)

water, glycerine, Lidocaine Lsopropyl palmitate, Aloe barbadensis leaf juice, Retinol,Helianthus annuus (sunflower)seed oil, Glyceryl stearate,

Pentylene glycol, Butyrospermum parkii (shea)butter,Cetyl alcohol, Piper methysticum leaf/root/stem extract, Peg-100 stearate, Tocopheryl acetate.

Purpose

Local Anesthetic

Warnings

For external use only

When using this product

  • Do not get into eyes.
  • Do not exceed recommend dosage unless directed by doctor.
  • Do not put this product into rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

  • 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. Do not use if allergic to any ingredients.

If pregnant or breastfeedingask a health professional before use.

Directions
  • When practical clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or bloating 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
  • To use finger cots: roll one finger cot over finger. Gently squeeze cream on to finger cot. Smooth a layer of the cream.
Product Label (Product label)

Other Information (Other information)

Store at room temperature. Avoid direct sunlight. Do not use if temper evident packaging has been breached or is missing.

Active Ingredients (Active ingredients)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)