Label: INSTANT HAND SANITIZER- alcohol 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 July 10, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses:

    • Cleansing gel for hands that need frequent care.
    • Decrease bacteria on skin.
    • Recommended for repeated use.
  • Warnings:

    For external use only. Flammable, keep away from fire or flame.

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with water

    Stop use and ask doctor if

    • irritation and redness develop and persists for more than 72 hours

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

  • Directions

    • place a small amount into one hand
    • spread over both hands and wrist
    • rub into the skin until dry
    • do not wipe off; no rinsing required
  • Other Information

    • store at 55° to 82°F
  • Inactive Ingredients

    aloe vera, carbomer, fragrance, purified water, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - 2 fl. oz. Label

    Apple Scent

    NEW CLEAR FORMULA

    Monarch®

    Hydrating Instant Hand Sanitizer

    Cleansing gel for
    hands that need frequent care.
    Decreases bacteria on skin.

    Enriched with Aloe Vera.
    Leaves hands feeling
    smooth and silky.

    Order No. H6500-N (16 oz. Bottle)

    Distributed By

    AIR TECHNIQUES

    equipped for life®

    www.airtechniques.com

    1295 Welt Whitman Road

    Melville, NY 11747-3062

    Net Contents:

    2 fl. oz. / 60mL

    Rev. A

    Principal Display Panel - 2 fl. oz. Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - 16 fl. oz. Label

    Apple Scent

    NEW CLEAR FORMULA

    Monarch®

    Hydrating Instant Hand Sanitizer

    Cleansing gel for
    hands that need frequent care.
    Decreases bacteria on skin.

    Enriched with Aloe Vera.
    Leaves hands feeling
    smooth and silky.

    Order No. H6500-N

    Net Contents: 16 fl. oz. / 473 mL

    Distributed By

    AIR TECHNIQUES

    equipped for life®

    Rev. A

    Principal Display Panel - 16 fl. oz. Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69965-8111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol700 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69965-8111-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2015
    2NDC:69965-8111-260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2015
    Labeler - Air Techniques (043835081)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69965-8111)