FDA.reportPublic FDA data

RECTICARE

Manufacturer
Ferndale Laboratories, Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:34

Label at a glance#

ProductRECTICARE
Active ingredientLIDOCAINE, GLYCERIN
Label structure7 sections

Indications and uses

helps relieve the pain, itching and burning associated with anorectal disorders temporarily provides a coating for relief of anorectal discomforts temporarily protects irritated and inflamed perianal skin

Dosage and administration

when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly gently apply wipe to the affected area by patting and then discard adults and children 12 years & older: apply up to 6 times daily - or after each bowel movement children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Glycerin 20% w/w

Purpose

OTC - PURPOSE SECTION

Lidocaine 5% w/w........................................Local anesthetic

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

Uses

INDICATIONS & USAGE SECTION

  • helps relieve the pain, itching and burning associated with anorectal disorders
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects irritated and inflamed perianal skin

Warnings

WARNINGS AND PRECAUTIONS SECTION

For external use only

Do not

WARNINGS SECTION

  • exceed the recommended daily dosage unless directed by a doctor
  • put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - QUESTIONS SECTION

  • an allergic reaction develops
  • condition worsens or does not improve witin 7 days
  • redness, irriation, swelling, pain or other symptoms begin or increase
  • bleeding occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical attention 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 thoroghly
  • gently apply wipe to the affected area by patting and then discard
  • adults and children 12 years & older: apply up to 6 times daily - or after each bowel movement
  • children under 12 years: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, citric acid, purified water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontpouchfrontpouch

pouchbackpouchback

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1602013lidocaine HCl 5 % / glycerin 20 % Medicated PadPSN3
1602019RectiCare 5 % / 20 % Medicated PadPSN3
1602019glycerin 200 MG/ML / lidocaine 43 MG/ML Medicated Pad [Recticare Wipes]SBD3
1602013glycerin 200 MG/ML / lidocaine 43 MG/ML Medicated PadSCD3
1602013glycerin 20 % / lidocaine 4.3 % (as lidocaine HCl 5 % ) Medicated PadSY3
1602013glycerin 20 % / lidocaine HCl 5 % Medicated PadSY3
1602019Recticare Wipes (glycerin 20 % / lidocaine 4.3 % (as lidocaine HCl 5 % )) Medicated PadSY3
1602019Recticare Wipes (glycerin 20 % / lidocaine HCl 5 % ) Medicated PadSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0980-65RECTICARE12 in 1 CARTONCLOTH123
0496-0980-76RECTICARE6 g in 1 POUCHCLOTH63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0980RECTICARE (LIDOCAINE AND GLYCERIN) CLOTH [FERNDALE LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20241220_2b94136a-4975-2925-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0980-65EA - Each0496-0980046a699c-669a-453e-b9af-c8e82d87b28412022-07-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0496-09800496-0980-76, 0496-0980-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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

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
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
ndc (package): 0496-0980-65
ndc (package): 0496-0980-76
ndc (product): 0496-0980
ndc11 (package): 00496098065
ndc11 (package): 00496098076
spl id: 297a27f1-089b-38aa-e063-6394a90adea1
spl set id: 2b94136a-4975-2925-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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