SANITIZER WIPES- sanitizing wipes liquid 
Organic Filling Solutions, LLC

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 an alcohol wipe manufactured in the USA

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, 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 (3.2% v/v)
  3. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Multi-purpose

Use

Single use wipes for hands. Close properly after dispensing to maintain purity, as alcohol by nature evaporates quickly. Dispose properly. Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.

Warnings

For external use only, hands, general cleaning. Does not replace wipes for medical procedures. Flammable; keep away from fire or flame. Do not ingest.

Do not use

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Stop use and ask a doctor if irritation or redness develop. Condition persists for more than 72 hours

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, purified water USP

Package Label - Principal Display Panel

Wipes Label Image230 mL NDC: 76830-501-07

SANITIZER WIPES 
sanitizing wipes liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76830-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL172.5 mL  in 230 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 7.5 mL  in 230 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76830-501-07230 mL in 1 PACKET; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Organic Filling Solutions, LLC (080759841)
Establishment
NameAddressID/FEIBusiness Operations
Organic Filling Solutions, LLC080759841manufacture(76830-501)

Revised: 8/2020
Document Id: ad52ff6f-5364-8747-e053-2a95a90ac126
Set id: ad530baa-1618-0d7b-e053-2995a90adc50
Version: 1
Effective Time: 20200820
 
Organic Filling Solutions, LLC