GRANULOTION Hemorrhoidal Lotion

Manufacturer
GL Health, Inc.
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:33:46

Label at a glance#

ProductGRANULOTION Hemorrhoidal
Active ingredientMENTHOL, ZINC OXIDE
Label structure6 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.11%

Zinc Oxide 5.1%

PURPOSE

OTC - PURPOSE SECTION

Analgesic, Anesthetic and Antipruritic

Astringent

USE

INDICATIONS & USAGE SECTION

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.

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucans, Cetearly Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycrrhiza Glabra (Licorice Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Potassium Alum, Tocopheryl Acetate (Vitamin E), FDandC Blue 1.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1492403Granulotion 0.11 % / 5.1 % Topical LotionPSN3
1492398menthol 0.11 % / zinc oxide 5.1 % Topical LotionPSN3
1492403menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]SBD3
1492398menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical LotionSCD3
1492403Granulotion (menthol 0.11 % / zinc oxide 5.1 % ) Topical LotionSY3
1492398Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical LotionSY3
1492403Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]SY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82897-293-00GRANULOTION Hemorrhoidal3.3 mL in 1 PACKETLOTION3.33

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82897-29382897-293-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
ndc (package): 82897-293-00
ndc (product): 82897-293
ndc11 (package): 82897029300
spl id: 48c0cb84-caef-ea0d-e063-6394a90a87de
spl set id: 1a32741c-5e4a-40e5-b15a-8233c5bdb92b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.