Ocean Citron Hand Sanitizer Gel

Ocean Citron Hand Sanitizer by

Drug Labeling and Warnings

Ocean Citron Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Antica Farmacista, LLC, SALON TECHNOLOGIES INTERNATIONAL, INC, PRO SKIN SOLUTIONS, INC. DBA ACTIVE COSMETICS MANUFACTURING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCEAN CITRON HAND SANITIZER- alcohol gel 
Antica Farmacista, LLC

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Ocean Citron Hand Sanitizer Gel

Drug Facts

Active Ingredient

Ethyl Alcohol, Denatured 65%

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 appears. 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.

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

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, PEG-12 Dimethicone, Fragrance.

473ML / 16 FL. OZ.

NDC: 80097-007-01 Label

OCEAN CITRON HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80097-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80097-007-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202106/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)06/01/202106/24/2023
Labeler - Antica Farmacista, LLC (171114395)
Registrant - SALON TECHNOLOGIES INTERNATIONAL, INC (877118302)
Establishment
NameAddressID/FEIBusiness Operations
PRO SKIN SOLUTIONS, INC. DBA ACTIVE COSMETICS MANUFACTURING174120506manufacture(80097-007)
Establishment
NameAddressID/FEIBusiness Operations
SALON TECHNOLOGIES INTERNATIONAL, INC877118302manufacture(80097-007)

Revised: 1/2024
Document Id: 0ec40e29-458f-b948-e063-6394a90a9c30
Set id: c3b6886d-9271-4c87-e053-2a95a90ad9c0
Version: 2
Effective Time: 20240112
 
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