FDA.reportPublic FDA data

HemoTreat

Manufacturer
Global Treat srl
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:34:28

Label at a glance#

ProductHemoTreat
Active ingredientCAMPHOR (SYNTHETIC)
Label structure13 sections

Indications and uses

Helps relieve itching and discomfort associated with hemorrhoids and anorectal disorders Temporarily relieves pain associated with anorectal inflammation and inflamed hemorrhoidal tissues May provide cooling sensation

Dosage and administration

Adults When practical, cleanse the affected area with mild soap and warm water Gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product. Detach one suppository from the strip, remove the foil wrapper before inserting into the rectum as follows: Hold suppository with rounded end up Carefully separate foil tabs by inserting tip of fingernail at the end Slowly and evenly p...

Storage and handling

Store at 15-25°C (59-77°F) Protect from excessive moisture Keep away from direct sunlight

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

DL-CAMPHOR (2.5%) wt/wt

Purposes

OTC - PURPOSE SECTION

Analgesic

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve itching and discomfort associated with hemorrhoids and anorectal disorders
  • Temporarily relieves pain associated with anorectal inflammation and inflamed hemorrhoidal tissues
  • May provide cooling sensation

Warnings

WARNINGS SECTION

For rectal use only

OTC - DO NOT USE SECTION

Do not use for more than 30 consecutive days

When using this product do not exceed the recommended daily dosage, unless directed by a doctor

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Bleeding occurs
  • Condition worsens or does not improve within seven days
  • Signs of a local infection appear
  • Certain person can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside of if redness, irritation, swelling, pain, and or other symptoms develop or increase, discontinue use and consult a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a poison Control Center right away 1 (800) 222-1222.

Children under 12 years: consult a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

Adults

  • When practical, cleanse the affected area with mild soap and warm water
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product.
  • Detach one suppository from the strip, remove the foil wrapper before inserting into the rectum as follows:
    • Hold suppository with rounded end up
    • Carefully separate foil tabs by inserting tip of fingernail at the end
    • Slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides to expose the suppository
    • Remove exposed suppository from wrapper
    • Insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement

Other Information

STORAGE AND HANDLING SECTION

  • Store at 15-25°C (59-77°F)
  • Protect from excessive moisture
  • Keep away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Extract, Calendula Officinalis Extract, Achillea Millefolium Extract, Ethanol, Clove Oil, Witepsol H15, Phenoxyethanol, Ethylhexylglycerin, BHA

OTC - QUESTIONS SECTION

Manufactured by SC Global Treat SRL

157 Portului Street, 800211, Galati, Romania

Web: www.hemotreat.com

EMail: contact@hemotreat.com

Questions? Call: 1 (800) 580-2238

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69758-328-88

HemoTreat

Hemorrhoidal Suppositories

Product LabelProduct Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69758-328-882021-07-23C16284748780-1c7ccaba7-2775-fd44-e053-dadaa90aa01bHemoTreat (69758-328)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69758-328-88HemoTreat3 g in 1 POUCHSUPPOSITORY36
69758-328-88HemoTreat12 in 1 CARTONSUPPOSITORY126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69758-328HEMOTREAT (CAMPHOR) SUPPOSITORY [GLOBAL TREAT SRL]6Legacy NDC, 2 package rows20201203_15659e24-7446-498d-9bd3-8d0166bbb994.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69758-32869758-328-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ACHILLEA MILLEFOLIUM OIL97P5D0WG43IACT
ALCOHOL3K9958V90MIACT
CLOVE OIL578389D6D0IACT
HYDROGENATED COCO-GLYCERIDESXDD37N2GPRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
b585d2eb-ee09-3e99-e053-2995a90a950a15659e24-7446-498d-9bd3-8d0166bbb9942020-12-02WarningsExact identifier
spl id: b585d2eb-ee09-3e99-e053-2995a90a950a
spl set id: 15659e24-7446-498d-9bd3-8d0166bbb994

Reported adverse events (FAERS/openFDA)#

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