ETHYL ALCOHOL- alcohol gel 
Freshorize LTD

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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Freshorize Gel Hand Sanitizer

Inactive Ingredients

Water (Aqua), Glycertin, Carbomer, Propylene Glycol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Directions

Apply small amount ot hands and rub lightly until dry.

Supervise children in the use of the product.

Warnings:

Flammable. Keep away from fire or flames. For external use only.
Keep out of reach of children.
Avoid contact with eyes.
In case of contact, rinse eyes throroughly with water.
Stop use and ask a doctor if skin irritation develops.
If ingested, get medical help or contact a
Poison Control Centre immediatly.

Warnings

Keep out of reach of children.

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Avoid extreme temperatures.

Purpose

Antibacterial

Uses

To decrease bacteria on the skin.

Front Label area

Requires no water or towels.
Apply small amount to hands and rub lightly until dry.

Package Label

300 ml Hand Sanitizer

ETHYL ALCOHOL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52305-001
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.001 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.28 mL  in 100 mL
.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
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52305-001-30300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/17/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/17/2021
Labeler - Freshorize LTD (424168503)
Registrant - Freshorize LLC (018206924)

Revised: 3/2021
Document Id: bdc16d64-a0e2-4260-e053-2a95a90a6117
Set id: bdc16d64-a0e1-4260-e053-2a95a90a6117
Version: 1
Effective Time: 20210317
 
Freshorize LTD