Label: ALCOHOLADA GEL PAIN RELIEVING PAIN- lidocaine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 October 26, 2017

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Lidocaine Hydrochloride 0.5%

    Purpose

    Pain Relieving Gel

  • Uses

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

  • Warnings

    For external use only.

    Do not use 

    in large quantites, particularly over raw surfaces or blistered areas.

    When using this product 

    avoid contact with the eyes.

    Stop use and ask a doctor if

    conditions worsens, or if symptoms persist for more than 7 days or clears up nand occur again within a few days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under2 years of age: Consult a doctor.
  • Other Information

    • Store in a cool dry place
    • Protect from heat and light
  • Inactive ingredients

    Water (Aqua/Eau), Alcohol Denat. Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Sodium Hydroxide, FD&C #1 (C.I. 42090), Fragrance (Parfum)

  • Package Labeling:

    Label7

  • INGREDIENTS AND APPEARANCE
    ALCOHOLADA GEL PAIN RELIEVING PAIN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-173-0065 mL in 1 TUBE; Type 0: Not a Combination Product10/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/25/2017
    Labeler - Aruba Aloe Balm NV (855442273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aruba Aloe Balm NV855442273manufacture(53675-173)