Label: SCLERACARE LIDOCAINE HCL- lidocaine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 12, 2020

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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:

    • For external use only not intended for ingestion.

    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 Poinson Control Center right away.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
    • If pregnant or breast feeding, contact 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 EST)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SCLERACARE LIDOCAINE HCL 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73698-106
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    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:73698-106-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/10/2020
    Labeler - ScleraCare, LLC (114220391)