FDA.reportPublic FDA data

RectaSmoothe

Manufacturer
Leading Pharma, LLC | Lyne Laboratories, Inc.
Effective date
2017-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:38

Label at a glance#

ProductRectaSmoothe
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day. Children under 12 years of age: Consult a doctor To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a la...

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 Ingredient

OTC - ACTIVE INGREDIENT SECTION


Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS:

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator
Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Keep out of the 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, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day.
  • Children under 12 years of age: Consult a doctor
  • To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the 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

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

Lidocaine 5%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label
Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN2
1366789lidocaine 50 MG/ML Rectal CreamSCD2
1366789lidocaine 5 % Rectal CreamSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369315301302GTIN-13: 0369315301302
EAN-13: 0369315301302
GTIN-12: 369315301302
UPC-A: 369315301302
GTIN storage (14 digits): 00369315301302		label.jpg, carton.jpg
Data codeCode 1283134carton.jpg

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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-301-30RectaSmoothe1 in 1 CARTONCREAM12
69315-301-30RectaSmoothe30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-301RECTASMOOTHE (LIDOCAINE 5%) CREAM [LEADING PHARMA, LLC]2Legacy NDC, 2 package rows20171223_78120481-b780-4e41-885d-11e424d1f717.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-301-30GM - Gram69315-301c8fcbbee-b813-4a10-ba64-b23886154fa812016-06-14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69315-30169315-301-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
PETROLATUM4T6H12BN9UIACT
WHITE WAX7G1J5DA97FIACT

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
5519fefa-2964-faa7-e063-6394a90a3ab178120481-b780-4e41-885d-11e424d1f7172026-06-25WarningsExact identifier
spl set id: 78120481-b780-4e41-885d-11e424d1f717

Reported adverse events (FAERS/openFDA)#

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