Sanitizing Alcohol Wipes by Unitrex Ltd. Alcohol Wipes

Drug Details [pdf]

SANITIZING ALCOHOL WIPES- alcohol cloth
Unitrex Ltd.

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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Alcohol Wipes

Drug Facts

Active ingredient

Isopropyl Alcohol 75% v/v

Purpose

Antimicrobial

Use

To help reduce bacteria, fungi, and viruses on the skin

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

Do not use in the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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

Wet hands thoroughly with product and allow to dry.
Discard wipe in trash receptacle after use. Do not flush.
Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Distilled Water

sparoom

SANITIZING ALCOHOL WIPES

Kills 99.99% of Common Germs

Isopropyl Alcohol 75%

Storage Conditions:

Store in a cool and dry environment. Avoid high temperature environment and keep away from fire sources.

Shelf Life:

Sealed / Unopened: 2 years
Opened: 90 Days

Distributed by Unitrex Ltd. / SpaRoom
5060 Taylor Rd, Cleveland OH 44128
© 2020 Unitrex
Questions? Toll-Free 1-833-729-4859
Made in China

80 PCS Container

label

SANITIZING ALCOHOL WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78553-3910
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 78553-3910-1	80 in 1 CANISTER; Type 0: Not a Combination Product	06/01/2020	06/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2020	06/30/2023

Labeler - Unitrex Ltd. (062032343)

Revised: 1/2023

Document Id: f17242c8-6e53-5b70-e053-2a95a90ac332

Set id: a733ddaf-5e14-381f-e053-2995a90a286e

Version: 6

Effective Time: 20230104