PYURX- ethanol alcohol gel

PyurX by

Drug Labeling and Warnings

PyurX by is a Otc medication manufactured, distributed, or labeled by Novara LLC, Huizhou Duomei Daily Necessites Co., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• For hand washing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

• For external use only.
• Flammable. Keep away from heat or flame.

Do not use

• Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
• Do not use on children less than 2 months of age.

STOP USE

Stop use and ask a doctor if

• Irritation and rednessdevelop and persist for more than 72 hours.
  • Swallowed, get medical help or contact a poison control centerright away.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Place enough product in your palm to cover hands and rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F (43C)
• May discolor certain fabrics or surfaces

Inactive ingredients

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

Package Label - Principal Display Panel

500ml. NDC: 80527-251-50

INGREDIENTS AND APPEARANCE

PYURX 
ethanol alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80527-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80527-251-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

Labeler - Novara LLC (117659846)

Establishment
Name	Address	ID/FEI	Business Operations
Novara LLC		117659846	relabel(80527-251)

Establishment
Name	Address	ID/FEI	Business Operations
Huizhou Duomei Daily Necessites Co., LTD.		554530153	manufacture(80527-251)