Lemon, Verbena and Cedar Hand Sanitizer Gel

Lemon, Verbena and Cedar by

Drug Labeling and Warnings

Lemon, Verbena and Cedar 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]

LEMON, VERBENA AND CEDAR HAND SANITIZER- alcohol gel 
Antica Farmacista, LLC

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Lemon, Verbena and Cedar 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.

296ML / 10 FL. OZ.

NDC: 80097-003-01

LEMON, VERBENA AND CEDAR  HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80097-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80097-003-01	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/19/2020	06/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/19/2020	06/18/2022

Labeler - Antica Farmacista, LLC (171114395)

Registrant - SALON TECHNOLOGIES INTERNATIONAL, INC (877118302)

Establishment
Name	Address	ID/FEI	Business Operations
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing		174120506	manufacture(80097-003)

Establishment
Name	Address	ID/FEI	Business Operations
SALON TECHNOLOGIES INTERNATIONAL, INC		877118302	manufacture(80097-003)

Revised: 1/2024

Document Id: 0ec3faa1-b4d3-b3f6-e063-6394a90a2490

34390-5

Set id: ad1890b9-b709-c795-e053-2a95a90a58ce

Version: 2

Effective Time: 20240112