PUREXX ALCOHOL WIPES- alcohol cloth cloth

PUREXX Alcohol Wipes by

Drug Labeling and Warnings

PUREXX Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by SanitizeNow Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Sterile antiseptic wipe recommended for single use.

For use when soap and water are not available.

Warnings

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

Do not use

• In children less than 2 months of age
• As a diaper wipe
• On open skin wounds
• In eyes. In case of contact, rinse eyes thoroughly with water

WHEN USING

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wipe over the skin or affected area, recommended for single-use, properly dispose of the used wipe.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Hydrogen Peroxide, Glycerin, Fragrance.

Package Label - Principal Display Panel

10 in 1 PACKET NDC: 74988-201-10

50 in 1 PACKET NDC: 74988-201-50

72 in 1 PACKET NDC: 74988-201-72

100 in 1 PACKET NDC: 74988-201-99

INGREDIENTS AND APPEARANCE

PUREXX ALCOHOL WIPES 
alcohol cloth cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74988-201
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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74988-201-10	10 in 1 PACKET; Type 0: Not a Combination Product	09/09/2020
2	NDC: 74988-201-50	50 in 1 PACKET; Type 0: Not a Combination Product	09/09/2020
3	NDC: 74988-201-72	72 in 1 PACKET; Type 0: Not a Combination Product	09/09/2020
4	NDC: 74988-201-99	100 in 1 PACKET; Type 0: Not a Combination Product	09/09/2020

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

Labeler - SanitizeNow Inc. (117475870)

Establishment
Name	Address	ID/FEI	Business Operations
SanitizeNow Inc.		117475870	manufacture(74988-201)