ROOTS AROMATHERAPY- isopropyl alcohol cloth 
Vision Chemical Systems

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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Sanitizing Wipes

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. 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. On open skin wounds.

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 and ask 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.

Directions

Rub wipes on hands or hard surfaces to sanitize.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Glycerin, Hydrogen Peroxide, Purified Water USP

2070mL, 76789-030-01 Roots Aromatherapy Sanitizing Wipes

ROOTS AROMATHERAPY 
isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76789-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76789-030-012070 mL in 1 CANISTER; Type 0: Not a Combination Product08/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2020
Labeler - Vision Chemical Systems (143308000)
Registrant - Vision Chemical Systems (143308000)
Establishment
NameAddressID/FEIBusiness Operations
Vision Chemical Systems143308000manufacture(76789-030)

Revised: 1/2022
Document Id: d57ac4cd-47ad-488b-e053-2995a90a7c62
Set id: ac8a69f8-2941-2cad-e053-2a95a90a64eb
Version: 2
Effective Time: 20220113
 
Vision Chemical Systems