PYURX- disinfectant wet wipes cloth

PyurX by

Drug Labeling and Warnings

PyurX by is a Otc medication manufactured, distributed, or labeled by Novara LLC, NanTong Guarder Medical Technology Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

75% Alcohol Disinfectant Wet Wipes. 50 count

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizing

Use

• For hand sanitizing to decrease bacteria on skin.
• Recommened for repeated use.

Warnings

• 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.
• 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 thoroughly with water.
• Do not use on children less than 2 months of age.

STOP USE

• Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.
• Swallowed, get medical help or contact a poison control center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

• Children must be supervised when using this product.

Directions

• Wet hands thoroughly with product and allow to dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store at below or below 75F (24C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

glycerin, Aqua(water), Vitamin E, Aloe

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PYURX 
disinfectant wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80527-351
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
GLYCERIN (UNII: PDC6A3C0OX)	0.3 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80527-351-51	50 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/21/2020

Labeler - Novara LLC (117659846)

Establishment
Name	Address	ID/FEI	Business Operations
Novara LLC		117659846	relabel(80527-351)

Establishment
Name	Address	ID/FEI	Business Operations
NanTong Guarder Medical Technology Co.,Ltd.		554537961	manufacture(80527-351)