Drugplain

GRANULOTION Hemorrhoidal 1.1 mg/mL

MENTHOL, ZINC OXIDE · LOTION · GL Health, Inc.

No Recall History
Plain English

GRANULOTION Hemorrhoidal is a lotion containing menthol, zinc oxide at 1.1 mg/mL, taken topical. Manufactured by GL Health, Inc..

Key Facts

Brand Name
GRANULOTION Hemorrhoidal
Generic Name
MENTHOL, ZINC OXIDE
NDC Code (Product)
82897-293
Manufacturer
GL Health, Inc.
Strength
1.1 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M015
Marketing Start
05/20/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

application site erythema1 reports
application site nodule1 reports
application site pain1 reports
atrial fibrillation1 reports
blister1 reports
cystitis1 reports
drug ineffective1 reports
drug withdrawal convulsions1 reports
meningitis1 reports
prescribed overdose1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE Helps relieve local itching and discomfort of the perianal area. Temporarily forms a protective barrier over inflamed tissues to help prevent drying of tissues. For the temporary relief of pain, burning and skin irritation. Can help distract the pain and may provide cooling sensation.

Dosage & Administration

DIRECTIONS When practical, cleanse the affected area with mild soap and warm water. Pat or allow to air dry. Apply a layer of GranuLotion® up to 6 times daily for inflammation, 1 time per day for continued site maintenance. Use a soft tipped applicator for hard to reach areas. Repeat as needed to protect the skin or until the condition resolves.

Warnings

WARNINGS For external use only If condition worsens or does not improve within 7 days, consult a doctor Do not exceed the recommended daily dose unless directed by a doctor In case of bleeding, consult a doctor promptly Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor Keep out of reach of children.

Frequently Asked Questions

What is GRANULOTION Hemorrhoidal used for?

GRANULOTION Hemorrhoidal contains MENTHOL, ZINC OXIDE. It is a lotion taken topical. Consult your doctor for specific uses.

Is GRANULOTION Hemorrhoidal a controlled substance?

GRANULOTION Hemorrhoidal is not classified as a controlled substance by the DEA.

What is the generic name for GRANULOTION Hemorrhoidal?

The generic name for GRANULOTION Hemorrhoidal is MENTHOL, ZINC OXIDE. There are 6 other brand versions of MENTHOL, ZINC OXIDE.

What is the NDC code for GRANULOTION Hemorrhoidal 1.1 mg/mL?

The NDC (National Drug Code) for GRANULOTION Hemorrhoidal 1.1 mg/mL is 82897-293, listed by GL Health, Inc..

Product NDC

82897-293

Package NDC

82897-293-00

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)