Alcohol Based Hand Sanitizer

Ethyl Alcohol by

Drug Labeling and Warnings

Ethyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Freshorize Ltd, Freshorize USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ETHYL ALCOHOL- alcohol gel 
Freshorize Ltd

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Alcohol Based Hand Sanitizer

Inactive Ingredients

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl, Aloe Barbadensis Leaf Juice.

Directions

Wet hands thoroughly with product

Briskly rub hands together until dry

supervise children under 6 years in the use of this product

Warnings

For external use only.

Flammable, keep away from fire and flame.

Do not use in the eyes. In case of contact, rinse eyes throughly with water.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Warnings

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

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Store at 20ºC to 25ºC (68º to 77ºF)

May discolour certain fabrics

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

There are no specific directions. It is a hand sanitizer with the directions for use to just add to your hand and briskly rub until dry.
Typical use would be one pump.

Label

ETHYL ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52305-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	37.307 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.3 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.001 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.001 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208)	0.28 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52305-001-01	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023
2	NDC: 52305-001-02	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023
3	NDC: 52305-001-03	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023
4	NDC: 52305-001-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/15/2020	12/31/2023

Labeler - Freshorize Ltd (424168503)

Registrant - Freshorize USA LLC (078206924)

Revised: 12/2023

Document Id: 0c56a2f2-aac1-9f96-e063-6394a90a2428

34390-5

Set id: a7ac0e16-d13a-b55e-e053-2a95a90a0f39

Version: 5

Effective Time: 20231212