Label: CLAREE- hand sanitizer gel antiseptic 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 January 29, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • INDICATIONS & USAGE

    Uses:

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • DOSAGE & ADMINISTRATION

    Directions:

    Place half a teaspoonful of product in one hand.  Spread on both hands and rub into the skin until dry (approximately 30 seconds).
    Children should be supervised when using this product.

  • WARNINGS AND PRECAUTIONS

    Warnings:

    Flammable, keep away from fire or flame.

    For external use only.

    Do not use in the eyes.

    Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours consult a doctor.

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Other Information:

    • Store at 20 (degrees C) to 25 (degrees C)  [68 degrees F to 77 degrees F]
    • May discolor certain fabrics
  • INACTIVE INGREDIENT

    Inactive Ingredients:  Carbomer, DMDM Glycolyl Hydantoin, Hydrogenated Castor Oil, PEG-40,
    Propylene Glycol, Triethanolamine, Vitamin E, Water

  • ACTIVE INGREDIENT

    Active Ingredients                  Purpose
    Ethyl Alcohol 62%                      Antiseptic

  • DESCRIPTION

    Questions or comments?

    1-888 (OK-HERBION)-654-3724, Monday through Friday, 9am-5pm

    Manufactured for:
    Herbion USA Inc.
    Williamsville, NY 14221
    1-888- (OK-HERBION)-654-3724
    info.us@herbion.com
    www.herbion.com

  • PRINCIPAL DISPLAY PANEL

    Claree

    Hand Sanitizer Gel

    Antiseptic

    Claree Label

  • INGREDIENTS AND APPEARANCE
    CLAREE 
    hand sanitizer gel antiseptic gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37 mL  in 60 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44237-400-6060 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/01/2010
    Labeler - Herbion Pakistan (Pvt.) Ltd. (645482936)
    Registrant - Herbion Pakistan (Pvt.) Ltd. (645482936)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbion Pakistan (Pvt.) Ltd.645482936manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!