Sugardoh Ouchie Relief Roller

Manufacturer
Sugardoh LLC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:10:46

Label at a glance#

ProductSugardoh Ouchie Relief Roller
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

temporarily relieves pain and itching due to anorectal disorders

Dosage and administration

When practical, clean 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 to the affected area up to 6 times a day. Children under 12 years of age : Consult a doctor.

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

temporarily relieves pain and itching due to anorectal disorders

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put htis product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

When practical, clean 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 to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • Store at USP controlled room termperature 20º - 25º C (68º - 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Camellia Sinensis Leaf Extract, Citral, Denatonium benzoate, Fragrance, Hexyl Cinnamal, Isopulegol, Limonene, Linalool, Menthoxypropanediol, PVP, t-Butyl Alcohol, Water

Questions or comments

OTC - QUESTIONS SECTION

support@sugardoh.co

(737) 295-9222

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83987-001SUGARDOH OUCHIE RELIEF ROLLER (LIDOCAINE) GEL [SUGARDOH LLC]1Unmatched20240229_0eb3a81d-d178-cc52-e063-6394a90a9697.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83987-00183987-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
44599d58-4efa-2fc3-e063-6394a90a7bd00eb3a81d-d178-cc52-e063-6394a90a96972025-11-24WarningsExact identifier
spl set id: 0eb3a81d-d178-cc52-e063-6394a90a9697

Reported adverse events (FAERS/openFDA)#

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