Label: SUGARDOH OUCHIE RELIEF ROLLER- lidocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • 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

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

  • INGREDIENTS AND APPEARANCE
    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)
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