FRESSLY- alcohol gel 
Mid Oak Distillery

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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This is a hand sanitizer manufactured according to the part333a OTC monograph.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with Center For Disease Control (CDC) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Purified Water
  5. Hydroxypropyl Cellulose
  6. Aloe Leaf

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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 a Poison Control Center right away.

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 a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, hydroxypropyl cellulose, aloe leaf

Package Label - Principal Display Panel

Flip Top 8.4 Oz248.42mL NDC: 77225-008-01

FRESSLY 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77225-008
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
WATER (UNII: 059QF0KO0R) 28.8 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) 0.03 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77225-008-01248.42 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Mid Oak Distillery (040273626)
Registrant - Fressly (117492887)
Establishment
NameAddressID/FEIBusiness Operations
Mid Oak Distillery040273626manufacture(77225-008)

Revised: 5/2020
Document Id: a6b617be-ed39-0b98-e053-2995a90afd9f
Set id: a6b6273a-01f1-403a-e053-2995a90ab939
Version: 1
Effective Time: 20200528
 
Mid Oak Distillery