HAND SANITIZER- ethyl alcohol gel 
DERMARITE INDUSTRIES, LLC

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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GELRITE 75

Active Ingredient(s)

Ethyl Alcohol 75% Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For cleansing/sanitizing of the hands when soap and water are not available.

Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame. Avoid contact with eyes. In case of contact, flush thoroughly with water. Stop use and seek medical attention if skin irritation develops.

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. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

Apply Generously, work into hands and allow to dry without wiping.

Children under six should be supervised while using this product.

Other information

Inactive ingredients

Deionized Water, glycerol, Carbomer, Triethanolamine

Questions?

Call 1-800-337-6296

Mon-Fri 9AM- 5PM EST.

Package Label - Principal Display Panel

GelRite8 oz NDC: 61924-114-08

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-114-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/18/2020
2NDC:61924-114-16500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/18/2020
3NDC:61924-114-04118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/18/2020
Labeler - DERMARITE INDUSTRIES, LLC (883925562)

Revised: 1/2022
Document Id: d57d3921-085a-6640-e053-2a95a90a6116
Set id: a85f1809-1256-6b93-e053-2a95a90ad1ad
Version: 4
Effective Time: 20220113
 
DERMARITE INDUSTRIES, LLC