FDA.reportPublic FDA data

RECTICARE ADVANCED

Manufacturer
Ferndale Laboratories, Inc.
Effective date
2016-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:45

Label at a glance#

ProductRECTICARE ADVANCED
Active ingredientGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 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 apply wipe to the affected area by patting and then discard. 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 20%w/w

Lidocaine 5% w/w

Phenylephrine HCl 0.25% w/w

Purpose

OTC - PURPOSE SECTION

Glycerin 20%w/w.........................................Protectant

Lidocaine 5% w/w........................................Local Aneshtetic

Phenylephrine HCl 0.25% w/w.....................Vasoconstrictor

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
  • thryoid 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 Poison Contol Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Gently apply wipe to the affected area by patting and then discard.
  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, citric acid, purified water

Questions?

OTC - QUESTIONS SECTION

Toll free (888) 548-0900

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WipePouchFrontWipePouchFront

WipePouchBackWipePouchBack

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0496-09790496-0979-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE98PI200987ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM

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
97a36b26-c730-7afc-e053-2995a90a0ea494d07482-60b0-4a45-8f79-9723de3cf1ba2019-11-18WarningsExact identifier
spl set id: 94d07482-60b0-4a45-8f79-9723de3cf1ba

Reported adverse events (FAERS/openFDA)#

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