Label: CINNAMON BARK SANITIZER- alcohol spray
CINNAMON BARK HAND SANITIZER- hand sanitizer 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 2, 2020

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  • SPL UNCLASSIFIED SECTION

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with FDA recommendations: Classification of OTC Consumer Antiseptic Rub Active Ingredients in the 1994 TFM and in the 2016 Proposed Rule. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (60-90%), volume/volume (v/v)) in an aqueous solution denatured

  • Active Ingredient(s)

    Alcohol 75%(Gel) - 80% (Spray) v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP, Cinnamon Bark Essential Oil

  • Package Labels - Front and Rear

    Essential Oil Sanitizer Spray Cinnamon Bark 4oz

    (118 ml /4 fl oz) NDC: 80749-200-10

    (118 ml /4 fl oz) NDC: 80749-200-10

    Essential Oil Hand Sanitizer Cinnamon Bark 1oz

    (29.5 ml /1 fl oz.) NDC: 80749-200-20

    (29.5 ml /1 fl oz.) NDC: 80749-200-20

    Essential Oil Hand Sanitizer Cinnamon Bark 16oz

    (473ml / 16 fl oz.) NDC: 80749-200-21

    (473ml / 16 fl oz.) NDC: 80749-200-21

    Sanitizer Rear Label

    rear labels for all sanitizers

  • INGREDIENTS AND APPEARANCE
    CINNAMON BARK SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80749-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL23.66 mL  in 29.57 mL
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON OIL (UNII: E5GY4I6YCZ) 0.09 mL  in 29.57 mL
    WATER (UNII: 059QF0KO0R) 5.36 mL  in 29.57 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.43 mL  in 29.57 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.04 mL  in 29.57 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80749-100-10118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/19/2020
    CINNAMON BARK HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80749-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.2 mL  in 29.57 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.04 mL  in 29.57 mL
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.31 mL  in 29.57 mL
    CINNAMON OIL (UNII: E5GY4I6YCZ) 0.09 mL  in 29.57 mL
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) 0.96 mL  in 29.57 mL
    WATER (UNII: 059QF0KO0R) 5.4 mL  in 29.57 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.4 mL  in 29.57 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.15 mL  in 29.57 mL
    Product Characteristics
    Colorwhite (Mainly Clear Gel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80749-200-2029.57 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/19/2020
    2NDC:80749-200-21473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/19/2020
    Labeler - Morning Star Aesthetics (117675328)
    Registrant - Thomas D Smith (117675328)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morning Star Aesthetics117675328pack(80749-100, 80749-200) , relabel(80749-100, 80749-200) , repack(80749-100, 80749-200) , label(80749-100, 80749-200) , manufacture(80749-100, 80749-200)
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