Recticare Advanced Hemorrhoidal Cream

Manufacturer
Ferndale Laboratories, Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:08

Label at a glance#

ProductRecticare Advanced
Active ingredientLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HYDROCHLORIDE, PETROLATUM
Label structure8 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...

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

Lidocaine 5% w/w
Mineral Oil 17% w/w
Phenylephrine HCl 0.25% w/w
White Petrolatum 39% w/w

Purpose

OTC - PURPOSE SECTION

Lidocaine 5% w/w....................................Local anesthetic
Mineral Oil 17% w/w................................Protectant
Phenylephrine HCl 0.25% w/w.................Vasoconstrictor
White Petrolatum 39% w/w.....................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

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

ceteth 20, cetostearyl alcohol, citric acid, propylparaben, purified water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Side1Side1Side2Side2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1745450lidocaine 5 % / mineral oil 17 % / petrolatum 39 % / phenylephrine HCl 0.25 % Topical CreamPSN6
1745455RectiCare Advance Cream 5 % / 17 % / 37 % / 0.25 % Topical CreamPSN6
1745455lidocaine 50 MG/ML / mineral oil 170 MG/ML / petrolatum 390 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Topical Cream [RectiCare Advance Cream]SBD6
1745450lidocaine 50 MG/ML / mineral oil 170 MG/ML / petrolatum 390 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Topical CreamSCD6
1745450lidocaine 5 % / mineral oil 17 % / petrolatum 39 % / phenylephrine hydrochloride 0.25 % Topical CreamSY6
1745455RectiCare Advance Cream (lidocaine 5 % / mineral oil 17 % / petrolatum 37 % / phenylephrine hydrochloride 0.25 % ) Topical CreamSY6
1745455RectiCare Advance Cream (lidocaine 50 MG/ML / mineral oil 170 MG/ML / petrolatum 370 MG/ML / phenylephrine hydrochloride 2.5 MG/ML) Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0978-15Recticare Advanced15 g in 1 TUBECREAM156
0496-0978-30Recticare Advanced30 g in 1 TUBECREAM306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0978RECTICARE ADVANCED (LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM) CREAM [FERNDALE LABORATORIES, INC.]6Current NDC, Legacy NDC, 2 package rows20241219_209212a7-7b6e-4b26-9f31-0eeb76f026bf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0978-30GM - Gram0496-0978923f2095-3951-442e-a7f8-b7c01e8fe8ac12021-04-08

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0496-09780496-0978-15, 0496-0978-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
ndc (package): 0496-0978-30
ndc (package): 0496-0978-15
ndc (product): 0496-0978
ndc11 (package): 00496097815
ndc11 (package): 00496097830
spl id: 297a0bd4-5b11-10cd-e063-6394a90af77a
spl set id: 209212a7-7b6e-4b26-9f31-0eeb76f026bf

Reported adverse events (FAERS/openFDA)#

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