FDA.reportPublic FDA data

Hemorrhoid relief cream

Manufacturer
Velocity Pharma LLC
Effective date
2020-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:09:59

Label at a glance#

ProductHemorrhoid Relief
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, PETROLATUM, GLYCERIN, LIDOCAINE
Label structure9 sections

Storage and handling

Other information store at 20–25°C (68–77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
GlycerinProtectant
LidocaineLocal anesthetic
Phenylephrine HCl

Vasoconstrictor

White PetrolatumProtectant

INDICATIONS & USAGE SECTION

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20–25°C (68–77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera gel, benzyl alcohol, butylated hydroxy toluene, carboxymethylcellulose sodium, cetomacrogol 1000, cetyl alcohol, cetyl alcohol, citric acid, disodium EDTA, glyceryl monostearate, light liquid paraffin, propylene glycol, purified water, stearyl alcohol, Vitamin E, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-855-314-1850

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1111

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
76168-32376168-323-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LIGHT MINERAL OILN6K5787QVPIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE98PI200987ACTIB

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
bd117a1e-ed37-0373-e053-2995a90a27b8b29bc9cb-9b58-3c32-e053-2a95a90a2b132021-03-08WarningsExact identifier
spl set id: b29bc9cb-9b58-3c32-e053-2a95a90a2b13

Reported adverse events (FAERS/openFDA)#

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