FDA.reportPublic FDA data

Rapidol Hemorrhoidal Cream (K)

Manufacturer
Pharmadel LLC
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:55:36

Label at a glance#

ProductRapidol Hemorrhoidal
Active ingredientGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM
Label structure8 sections

Indications and uses

for the temporary relief of local itching and discomfort associated with hemorrhoid anorectal inflammation temporarily shrinks hemorrhoidal tissue temporarily relieves the symptoms of perianal skin irritation

Dosage and administration

adults: when practical, cleanse the affected area with soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product apply externally to the affected area after a bowel movement, no more than 4 times daily children under 12 years of age : consult a doctor

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients

Purposes

Glycerin 14.4%...........................

Protectant
Phenylephrine HCl 0.25%..........Vasoconstrictor
Pramoxine HCl 1 %....................Local anesthetic
White petrolatum 15%................Protectant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of local itching and discomfort associated with
  • hemorrhoid
  • anorectal inflammation
  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves the symptoms of perianal skin irritation

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 of 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

  • do not exceed the 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 consult a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve within 7 days
  • bleeding occurs

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

KEEP OUT OF THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: when practical, cleanse the affected area with soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

apply externally to the affected area after a bowel movement, no more than 4 times daily

  • children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 60-77°F (20-25°C)
  • do not use if foil seal under cap is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, alpha tocopherol (Vit. E), butylated hydroxyanisole, carboxymethylcellulose sodium, cetostearyl alcohol, cetyl alcohol, citric acid monohydrate, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, panthenol, propylparaben, sodium benzoate, steareth-20, xanthan gum, water

Questions?​

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

Distributed by/ Distribuido por:

Pharmadel LLC

New Castle, DE 19720

Made in India/ Hecho en India

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp rapidol Hemorrhoidspdp rapidol Hemorrhoids

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-448RAPIDOL HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [PHARMADEL LLC]1Unmatched20240905_20ebce45-3a55-5e3d-e063-6394a90adc38.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-44855758-448-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
PANTHENOLWV9CM0O67ZIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARETH-20L0Q8IK9E08IACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT

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
437f9498-227c-5649-e063-6294a90acf6120ebce45-3a55-5e3d-e063-6394a90adc382025-11-13WarningsExact identifier
spl set id: 20ebce45-3a55-5e3d-e063-6394a90adc38

Reported adverse events (FAERS/openFDA)#

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