bloop fissure healing topical anorectal cream

bloop fissure healing topical anorectal cream
SPL v1
SPL
SPL Set ID 0b645092-ebc4-e4bb-e063-6294a90ad4cf
Route
topical
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
carbomer 940 benzyl alcohol cholesterol acai oil edetate disodium hydrogenated soybean lecithin propanediol isopropyl myristate pentaclethra macroloba seed oil polysorbate 80 .alpha.-tocopherol acetate water trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-14

Description

Lidocaine 5%


Medication Information

Warnings and Precautions

For external use only (skin of the perianal area and anal canal).

When using this product

  • 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

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • rectal bleeding occurs
  • 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
Active Ingredient

Lidocaine 5%

Indications and Usage
  • Helps relieve the pain, itching, and burning associated with hemorrhoids, fissures, and other anorectal disorders
Dosage and Administration
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Carefully apply medication to the perianal skin and anal canal with a clean finger
  • 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 immediately.

Section 51727-6

Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, water.

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Anorectal (hemorrhoidal)


Structured Label Content

Warnings and Precautions (34071-1)

For external use only (skin of the perianal area and anal canal).

When using this product

  • 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

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • rectal bleeding occurs
  • 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
Active Ingredient (55106-9)

Lidocaine 5%

Indications and Usage (34067-9)
  • Helps relieve the pain, itching, and burning associated with hemorrhoids, fissures, and other anorectal disorders
Dosage and Administration (34068-7)
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Carefully apply medication to the perianal skin and anal canal with a clean finger
  • 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
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, 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)

Anorectal (hemorrhoidal)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)