Label: ALCOHOLADA PAIN RELIEVING- 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 December 7, 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 quantities, 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 and 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 under 2 years of age: Consult a doctor.

  • Other Information

    • Store in a cool dry place

    • Protect from hear and light

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Vera (Aloe Barbadensis) Gel, Caprylyl Glycol, Chlorphenesin, FD&C Blue No.1, Fragrance (Parfum), Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water (Aqua).

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOLADA PAIN RELIEVING 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-164-00251 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/10/2017
    Labeler - Aruba Aloe Balm NV (855442273)