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
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)

Section 55106-9

Lidocaine 5%


Structured Label Content

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
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
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)

Section 55106-9 (55106-9)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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