FDA.reportPublic FDA data

HemoTreat

Manufacturer
Global Treat srl
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:34:31

Label at a glance#

ProductHemoTreat
Active ingredientPETROLATUM, LANOLIN, FAT, HARD, CAMPHOR (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 application of ointment With the help of the index finger, apply a generous layer of ointment For optimal results apply at least 2 times a day, morning and evening, for 5-7 consecutive days. Spread on to the affected area, generally on the exterior of the anus a...

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

White Petrolatum 21.3% wt/wt

Lanolin 21.25% wt/wt

Hard Fat 42.6% wt/wt

Camphor 2.5% wt/wt

Purposes

OTC - PURPOSE SECTION

Protectant

Protectant

Protectant

Analgesic

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

butylated hydroxyl anisole, calcium carbonate, ethanol, ethylparaben, eucalyptus oil, methylparaben, phenoxyethanol

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 consecutive 30 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 application of ointment
  • With the help of the index finger, apply a generous layer of ointment
  • For optimal results apply at least 2 times a day, morning and evening, for 5-7 consecutive days. Spread on to the affected area, generally on the exterior of the anus and in the vicinity of the anal orifice. Product should stay on affected area for several hours. Reapply if bathroom trip results in product removal.

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 69758-325-55

HemoTreat

Hemorrhoid Ointment

5 mL

Product LabelProduct Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69758-325-552021-07-23C16284748780-1c7ccaba7-1902-fd44-e053-dadaa90aa01bHemoTreat (69758-325)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69758-325-55HemoTreat5 in 1 BOXCREAM55
69758-325-55HemoTreat5 mL in 1 POUCHCREAM55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69758-325HEMOTREAT (WHITE PETROLATUM, LANOLIN, HARD FAT, CAMPHOR) CREAM [GLOBAL TREAT SRL]5Legacy NDC, 2 package rows20201203_b03e3664-7df8-453c-a322-64d344fb603b.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69758-32569758-325-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CALCIUM CARBONATEH0G9379FGKIACT
ALCOHOL3K9958V90MIACT
ETHYLPARABEN14255EXE39IACT
EUCALYPTUS OIL2R04ONI662IACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PETROLATUM4T6H12BN9UACTIB
LANOLIN7EV65EAW6HACTIB
FAT, HARD8334LX7S21ACTIB
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
b585d61b-4cad-3059-e053-2995a90a324eb03e3664-7df8-453c-a322-64d344fb603b2020-12-02WarningsExact identifier
spl id: b585d61b-4cad-3059-e053-2995a90a324e
spl set id: b03e3664-7df8-453c-a322-64d344fb603b

Reported adverse events (FAERS/openFDA)#

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