Label: ALOCANE- lidocaine hydrochloride and hydrocortisone acetate ointment

  • 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 2, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Silicones 94.5%Scar Management
    Hydrocortisone Acetate .5%Anti-Pruritic
  • Uses

    Scar management. For temporary relief of itching associated with minor skin irritations, inflammation and rashes.

  • Warnings

    For external use only.

    Do not use on children under 2 years of age. Consult a doctor. Do not use on mucous membranes.

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Children from 2-12 years of age ask a doctor

    Clean affected area with mild soap and water, dry thoroughly, apply twice daily. Allow to dry for 1 minute before coming into contact with clothing.

  • Other Information

    Store at 15° to 30° C (59° to 86°F)

  • Inactive Ingredients

    Allium Cepa (Onion) Bulb Extract, Aloe Barbadensis (Aloe) Leaf Juice, Dimethicone, Dimethicone Crosspolymer, Glycerine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helichrysum Italicum (Everlasting) Extract

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Quest Products, Inc.
    Pleasant Prairie, WI 53158

  • PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

    Onion Bulb
    Silicone
    +

    ADVANCED STRENGTH
    ALOCANE
    ®

    Scar Prevention
    Therapy Gel

    • Specially Formulated to Prevent the
      Formation of Scars
    • Reduces Visibility of Old Scars
    • Restores Elasticity to tissue
    • Smooths and Softens Skin

    Recommended by
    Physicians and Pharmacists

    MADE IN THE
    USA

    Net Wt
    2.5 fl. oz (75ml)

    PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ALOCANE 
    lidocaine hydrochloride and hydrocortisone acetate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS945 mg  in 1 mL
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ONION (UNII: 492225Q21H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-400-021 in 1 CARTON
    1NDC:68229-400-0175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/11/2014
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA965596435MANUFACTURE(68229-400)