HAND SANITIZER- alcohol gel 
RealChem Manufacturing Inc.

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.

----------

70% EtOH Unscented Gel HS with Aloe & Vit E

This is a 70% ethanol unscented gel hand sanitizer with added aloe and vitamin E, manufactured according to FDA guidance. T

Active Ingredient(s)

Alcohol 70% 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

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 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.

Directions

Other information

Inactive ingredients

glycerin, Rapidgel EZ1, purified water USP

Package Label - Principal Display Panel

118 mL NDC: 79363-706-04

ProtextRxx 70% Unscented Gel with Aloe and Vit E 4oz

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79363-706
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.516 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 0.886 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79363-706-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/06/2021
Labeler - RealChem Manufacturing Inc. (120491681)
Establishment
NameAddressID/FEIBusiness Operations
RealChem Manufacturing Inc117742005manufacture(79363-706) , pack(79363-706) , repack(79363-706)
Establishment
NameAddressID/FEIBusiness Operations
RealChem Manufacturing Inc117828480manufacture(79363-706) , pack(79363-706) , repack(79363-706)
Establishment
NameAddressID/FEIBusiness Operations
RealChem Manufacturing Inc120491681manufacture(79363-706) , pack(79363-706) , repack(79363-706)

Revised: 2/2021
Document Id: ba9f0d91-3f56-467f-e053-2995a90ab20b
Set id: ba9f5735-36e8-052e-e053-2a95a90ad000
Version: 1
Effective Time: 20210205
 
RealChem Manufacturing Inc.