rectoprotect (lidocaine 5% anorectal cream)

rectoprotect (lidocaine 5% anorectal cream)
SPL v4
SPL
SPL Set ID 1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb
Route
topical
Published
Effective Date 2025-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
aloe barbadensis leaf juice benzyl alcohol carbomer cholesterol isopropyl myristate mineral oil polysorbate 80 propylene glycol water tocopherol trolamine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-01-06

Purpose

Local anesthetic

Description

Lidocaine 5% w/w


Medication Information

Warnings

Uses

Temporarily relieves pain and itching due to anorectal disorders

Purpose

Local anesthetic

Directions
  • 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
Other Information
  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine

Description

Lidocaine 5% w/w

Section 51945-4

Active Ingredient

Lidocaine 5% w/w

Questions Or Comments?

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

www.akronpharma.com

When Using This Product
  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
Stop Use and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs 
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days
Keep Out of Reach of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.


Structured Label Content

Warnings

Uses

Temporarily relieves pain and itching due to anorectal disorders

Purpose

Local anesthetic

Directions
  • 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
Other Information (Other information)
  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Lidocaine 5% w/w

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

www.akronpharma.com

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs 
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days
Keep Out of Reach of Children. If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away. (Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.)


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