f725ecd1-96de-4f9f-94c9-d22c676285b2

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

Purpose

Local Anesthetic

Description

Lidocaine 5%


Medication Information

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.

Uses

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

Purpose

Local Anesthetic

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.
Other Information

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

Description

Lidocaine 5%

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.

Product Label

Active Ingredients

Lidocaine 5%


Structured Label Content

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.

Uses

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

Purpose

Local Anesthetic

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.
Other Information (Other information)

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

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.

Product Label (Product label)

Active Ingredients (Active ingredients)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)