SPL v1
SPL
SPL Set ID 1c809643-0cbe-568f-e063-6394a90a3210
Route
TOPICAL
Published
Effective Date 2024-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 Anhydrous Dextrose .alpha.-tocopherol Acetate Turmeric Glycerin Propylene Glycol Asian Ginseng Polysorbate 80 Isopropyl Myristate Water Cholesterol Trolamine Ascorbic Acid Indian Frankincense Bromelains Hydrogenated Soybean Lecithin Salix Alba Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-08

Description

Lidocaine 5%


Medication Information

Warnings and Precautions

For external use only.

When using this product

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

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
Indications and Usage

Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

Dosage and Administration
  • When practical, clean 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.
Description

Lidocaine 5%

Section 50565-1

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

Section 51727-6

Ascorbic acid, benzyl alcohol, boswellia serrata extract, bromelain, carbomer, cholesterol, curcuma long (turmeric) root extract, glucose, glycerin, hydrogenated lecithin, isopropyl myristate, panax ginseng root extract, polysorbate 80, propylene glycol, salix alba (willow) bark extract, tocopheryl acetate, triethanolamine, water.

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

Dosage and Administration (34068-7)
  • When practical, clean 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.
Warnings and Precautions (34071-1)

For external use only.

When using this product

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

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
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Ascorbic acid, benzyl alcohol, boswellia serrata extract, bromelain, carbomer, cholesterol, curcuma long (turmeric) root extract, glucose, glycerin, hydrogenated lecithin, isopropyl myristate, panax ginseng root extract, polysorbate 80, propylene glycol, salix alba (willow) bark extract, tocopheryl acetate, triethanolamine, water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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