FDA.reportPublic FDA data

Bottoms Up

Manufacturer
WSM Investment LLC dba Topco Sales | WSM Investment LLC. Topco Sales
Effective date
2017-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:30

Label at a glance#

ProductBottoms Up
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

OTC - PURPOSE SECTION

Anorectal

INDICATIONS & USAGE SECTION

For temporary relief of pain, soreness, or burning in the perianal area.

WARNINGS SECTION

  • For external use only. Do not use this product with a mechanical device.
  • Certain persons can develop allergic reactions to ingredients in this product.

If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

  • Do not exceed the daily recommended dosage
  • In case of any bleeding, discontinue use and consult a doctor.
  • Avoid contact with eyes, in case of eye contact, flush with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all drugs out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
  • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

DOSAGE & ADMINISTRATION SECTION

  • Cleanse affected area with mild soap and water.
  • Gently dry by patting or blotting with soft cloth or tissue before application.
  • Apply externally to the affected area up to 6 times daily.

OTHER SAFETY INFORMATION

  • Store at room temperature 20-25°C (68-77°F).
  • Tamper-Evident: Do not use if tamper evident seal under cap is broken or missing.

INACTIVE INGREDIENT SECTION

Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water (Aqua).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10319351031935

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1652104lidocaine 5 % Rectal GelPSN1
1652104lidocaine 0.05 MG/MG Rectal GelSCD1
1652104lidocaine 5 % Rectal GelSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69797-103-012020-01-31C16284748780-19d75b9d0-6eb3-f424-e053-dadaa90a57ce606958bb-33e8-6a69-e053-2991aa0ab0e4
69797-103-022020-01-31C16284748780-19d75b9d0-6eb3-f424-e053-dadaa90a57ce606958bb-33e8-6a69-e053-2991aa0ab0e4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69797-103-01Bottoms Up68 mL in 1 BOTTLELIQUID681
69797-103-02Bottoms Up186 mL in 1 BOTTLELIQUID1861

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69797-103BOTTOMS UP (LIDOCAINE) LIQUID [WSM INVESTMENT LLC DBA TOPCO SALES]1Legacy NDC, 2 package rows20171216_606958bb-33e8-6a69-e053-2991aa0ab0e4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69797-10369797-103-01, 69797-103-02

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
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPENTYLDIOL19NOL5474QIACT
CARBOXYMETHYLCELLULOSE CALCIUMUTY7PDF93LIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT

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
606958bb-33e9-6a69-e053-2991aa0ab0e4606958bb-33e8-6a69-e053-2991aa0ab0e42017-12-15WarningsExact identifier
spl id: 606958bb-33e9-6a69-e053-2991aa0ab0e4
spl set id: 606958bb-33e8-6a69-e053-2991aa0ab0e4

Reported adverse events (FAERS/openFDA)#

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