SUGARDOH OUCHIE RELIEF ROLLER- lidocaine gel 
Sugardoh LLC

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Sugardoh Ouchie Relief Roller

Drug Facts

Active Ingredient

Lidocaine 5%w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

Warnings

When using this product

  • 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

  • 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.

Directions

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

Inactive ingredients

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

support@sugardoh.co

(737) 295-9222

Product Packaging

1

SUGARDOH OUCHIE RELIEF ROLLER 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83987-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRAL (UNII: T7EU0O9VPP)  
ISOPULEGOL (UNII: 3TH92O3BXN)  
POVIDONE (UNII: FZ989GH94E)  
ALCOHOL (UNII: 3K9958V90M)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83987-001-011 in 1 BOX02/28/2024
144 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01502/28/2024
Labeler - Sugardoh LLC (118209443)

Revised: 1/2024
Document Id: 0eb3a81d-d179-cc52-e063-6394a90a9697
Set id: 0eb3a81d-d178-cc52-e063-6394a90a9697
Version: 1
Effective Time: 20240111
 
Sugardoh LLC