Label: DOM ORGANIC LAVENDER HAND SANITIZER- alcohol spray
DOM ORGANIC ROSEMARY HAND SANITIZER- alcohol spray

  • 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 April 12, 2021

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

  • Active Ingredient(s)

    Ethyl Alcohol 62%. Purpose: Antiseptic

  • 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

    • On 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 at 1-800-222-1222.

  • 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 at 1-800-222-1222.

  • Directions

    • Spray generously on your palms and backs of your hands. Make sure to rub all over and in between fingers.
    • Children under 6 years of age should be supervised 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

    Aqua (water), *Aloe Barbadensis leaf juice, *Chamomile extract, *Glycerin, *Rosmarinus offinalis (rosemary) oil

  • PURPOSE

    Antiseptic

  • Package Label - Principal Display Panel (8 fl oz Lavender)

    Label

  • Package Label Principal Display Panel (8 fl oz Rosemary)

    Label

  • INGREDIENTS AND APPEARANCE
    DOM ORGANIC LAVENDER HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81947-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.225 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.63 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 34.12 mL  in 100 mL
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81947-001-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/27/2021
    2NDC:81947-001-01250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2021
    DOM ORGANIC ROSEMARY HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81947-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.225 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.63 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 34.12 mL  in 100 mL
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81947-002-0460 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/27/2021
    2NDC:81947-002-03250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2021
    Labeler - Sani At Home Inc. (240337780)
    Registrant - Scents Alive (201050882)