Label: SCLERA CARE TOPICAL ANESTHETIC GEL- lidocaine hydrochloride gel

  • NDC Code(s): 73698-281-00, 73698-281-01
  • Packager: ScleraCare, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active Ingredient:

    Lidocaine hydrochloride 3.00%

    Purpose

    Topical Anesthetic

  • Uses:

    • For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

  • Warnings:

    • not intended for ingestion. For external use only

    When using this product

    • Avoid contact with eyes

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if

    symptoms persist for more than seven days.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away. • Do not apply to wounds or damaged skin. • Do not bandage tightly.

    If pregnant or breast feeding,

    • contact a physician prior to use.

  • Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: Consult a physician.

  • Inactive Ingredients:

    a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Opuntia Vulgaris (Prickly Pear) Extract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate-20, Sodium Alginate, Squalane, Triethanolamine.

  • Other Information:

    • Store at room temperature

  • Question?

    337-526-6744 (M-F) (9-5pm CST)

  • Package Labeling:5ml

    Label

  • Package Labeling:118ml

    Label2

  • INGREDIENTS AND APPEARANCE
    SCLERA CARE TOPICAL ANESTHETIC GEL 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73698-281
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SQUALANE (UNII: GW89575KF9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73698-281-005 mL in 1 PACKET; Type 0: Not a Combination Product03/21/2022
    2NDC:73698-281-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/21/2022
    Labeler - ScleraCare, LLC (114220391)
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