PYURX- ethanol alcohol gel 
Novara 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.

----------

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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 World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, 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. 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.

See ingreditents list for accurate list.

Active Ingredient(s)

Ethanol Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children. Children must be supervised in use of this product.

Directions

Other information

Inactive ingredients

Aqua(Water), Glycerin, Carbomer, Triethanolamine, Aloe, Tocopheryl Acetate (Vitamin E).

Package Label - Principal Display Panel

500ml. NDC: 80527-251-50 Front LabelBack Label

PYURX 
ethanol alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80527-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9) 0.1 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 4 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 4 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 13.8 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80527-251-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/07/2020
Labeler - Novara LLC (117659846)
Establishment
NameAddressID/FEIBusiness Operations
Novara LLC117659846relabel(80527-251)
Establishment
NameAddressID/FEIBusiness Operations
Huizhou Duomei Daily Necessites Co., LTD.554530153manufacture(80527-251)

Revised: 9/2020
Document Id: aeeb7c2e-240c-53aa-e053-2a95a90adf9c
Set id: aeeb47a7-0b21-093e-e053-2a95a90abef9
Version: 1
Effective Time: 20200909
 
Novara LLC