CLEAN MONSTER LAVENDER PEPPERMINT HAND SANITIZER- ethanol liquid 
Clean Monster LLC

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.

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Ethanol 70%

Purpose:

Antiseptic

Uses:

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 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 the Poison Control Center right away.

Directions:

Store at room temperature 20-25 °C (66-77 °F)

Inactive Ingredients:

Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha piperita (Peppermint) Oil, Tocopherol.

Clean Monster

CLEAN MONSTER LAVENDER PEPPERMINT HAND SANITIZER 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78723-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78723-001-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
2NDC:78723-001-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Clean Monster LLC (131398718)
Establishment
NameAddressID/FEIBusiness Operations
GPS Associates096942063manufacture(78723-001)

Revised: 6/2020
Document Id: a7d98845-f7cf-4c16-e053-2995a90a2219
Set id: a7d98845-f7ce-4c16-e053-2995a90a2219
Version: 1
Effective Time: 20200601
 
Clean Monster LLC