FDA.reportPublic FDA data

lidoForte Hemorrhoidal Cream

Manufacturer
Satius Pharmaceuticals, LLC
Effective date
2017-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:10:00

Label at a glance#

ProductlidoForte Hemorrhoidal
Active ingredientLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HYDROCHLORIDE, PETROLATUM
Label structure7 sections

Indications and uses

Helps relieve the pain, itching and burning associated with hemorrhoids Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders Temporarily provides a coating for relief of anorectal discomforts Temporarily protects irritated areas and inflamed perianal skin

Dosage and administration

When practical, cleanse the affected 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 4 times daily Children under 12 years of age: consult a doctor To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. S...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Mineral Oil 17% w/w

Phenylephrine HCI 0.25% w/w

White Petrolatum 39% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Protectant

Vasoconstrictor

Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps relieve the pain, itching and burning associated with hemorrhoids
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects irritated areas and inflamed perianal skin

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug for high blood pressure or depression

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Do not exceed recommended daily dosage unless directed by a doctor
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs to ingredients in this product
  • Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, cleanse the affected 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 4 times daily
  • Children under 12 years of age: consult a doctor
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information

SPL UNCLASSIFIED SECTION

Store at 25 degrees C (77 Degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F)
[see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (purified water), Benzyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Citric Acid, Dehydroacetic Acid

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
71890-31071890-310-01

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
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEHYDROACETIC ACID2KAG279R6RIACT
LIDOCAINE98PI200987ACTIB
MINERAL OILT5L8T28FGPACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML · Source PDF

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
07413526-c3ed-34ee-e063-6294a90a644c71b22b79-6a75-4918-a25f-725759ae8bee2023-10-08WarningsExact identifier
spl set id: 71b22b79-6a75-4918-a25f-725759ae8bee

Reported adverse events (FAERS/openFDA)#

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