GELRITE- hand sanitizer 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

Active Ingredient

Alcohol 65%

Purpose

Skin Protectant

​Uses

​Warnings

For external use only.

​Flammable. Keep away from heat and flame.

Avoid contact with eyes. ​In case of contact, flush thoroughly with water.

Stop use and ask a doctor if skin irritation develops.

.

Directions

Other Information

​Inactive ingredients

Water, Propylene Glycol, Carbomer, Polysorbate 20, Fragrance, t-Butanol, Triethanolamine, Tocopherol Acetate, Sodium Isostearoyl Lactate, Denatonium Benzoate

Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Keep out of reach of children

Keep out of reach of children. ​In case of accidental ingestion contact a physician or Poison Control Center right away

GelRite Package Label Principal Display Panel

Principal Display Panel

GELRITE 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
BUTANOL (MIXED ISOMERS) (UNII: WB09NY83YA)  
2,4,5-T-TROLAMINE (UNII: 9007L1DAXM)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-106-04118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/25/2006
2NDC:61924-106-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/25/2006
3NDC:61924-106-27800 mL in 1 BAG; Type 0: Not a Combination Product04/25/2006
4NDC:61924-106-341000 mL in 1 BAG; Type 0: Not a Combination Product04/25/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/25/2006
Labeler - DERMARITE INDUSTRIES, LLC (883925562)
Registrant - DERMARITE INDUSTRIES, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DERMARITE INDUSTRIES LLC883925562manufacture(61924-106)

Revised: 1/2022
Document Id: d57d3812-9482-56a6-e053-2a95a90aaa82
Set id: 4180193e-9d34-2ecf-e054-00144ff88e88
Version: 8
Effective Time: 20220113
 
DERMARITE INDUSTRIES, LLC