Bloop Fissure Healing Topical Anorectal Cream

Manufacturer
Three Nations Corp | Derma Care Research Labs, LLC
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:57

Label at a glance#

ProductBloop Fissure Healing Anorectal Topical
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal)

INDICATIONS & USAGE SECTION

  • Helps relieve the pain, itching, and burning associated with hemorrhoids, fissures, and other anorectal disorders

WARNINGS SECTION

For external use only (skin of the perianal area and anal canal).

When using this product

  • do not exceed recommended 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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Carefully apply medication to the perianal skin and anal canal with a clean finger
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day
  • Children under 12 years of age consult a doctor

INACTIVE INGREDIENT SECTION

Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN1
1366789lidocaine 50 MG/ML Rectal CreamSCD1
1366789lidocaine 5 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83838-153-01Bloop Fissure Healing Anorectal Topical1 in 1 CARTONCREAM11
83838-153-01Bloop Fissure Healing Anorectal Topical28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83838-153BLOOP FISSURE HEALING ANORECTAL TOPICAL (LIDOCAINE) CREAM [THREE NATIONS CORP]1Current NDC, 2 package rows20231201_0b645092-ebc4-e4bb-e063-6294a90ad4cf.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83838-15383838-153-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Bloop Fissure Healing Anorectal TopicalLIDOCAINEThree Nations Corp0b645092-ebc4-e4bb-e063-6294a90ad4cf2023-11-30WarningsExact identifier
ndc (package): 83838-153-01
ndc (product): 83838-153
ndc11 (package): 83838015301
spl id: 0b645092-ebc3-e4bb-e063-6294a90ad4cf
spl set id: 0b645092-ebc4-e4bb-e063-6294a90ad4cf