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

Description

Lidocaine 5% w/w

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Lidocaine 5% w/w

Uses

Temporarily relieves pain and itching due to anorectal disorders

Section 51945-4

Warnings

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
Active Ingredient

Lidocaine 5% w/w

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

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

Uses

Temporarily relieves pain and itching due to anorectal disorders

Section 51945-4 (51945-4)

Purpose

Local anesthetic

Warnings

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
Active Ingredient (Active ingredient)

Lidocaine 5% w/w

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

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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