GELRITE- hand sanitizer gel

GELRITE by

Drug Labeling and Warnings

GELRITE by is a Otc medication manufactured, distributed, or labeled by DERMARITE INDUSTRIES, LLC, DERMARITE INDUSTRIES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 65%

​ Purpose

Antiseptic

​Uses

• For handwashing to decrease bacteria on skin.
• Recommended for repeated use.

​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

• ​Wet hands thoroughly with product and allow to dry without wiping.
• Children under six should be supervised while using this product.

Other Information

• Do not store above 105°F
• May discolor some fabrics or surfaces
• You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

​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

INGREDIENTS AND APPEARANCE

GELRITE 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
BUTANOL (MIXED ISOMERS) (UNII: WB09NY83YA)
2,4,5-T-TROLAMINE (UNII: 9007L1DAXM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-106-04	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/25/2006
2	NDC: 61924-106-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/25/2006
3	NDC: 61924-106-27	800 mL in 1 BAG; Type 0: Not a Combination Product	04/25/2006
4	NDC: 61924-106-34	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/25/2006
5	NDC: 61924-106-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/25/2006

Labeler - DERMARITE INDUSTRIES, LLC (883925562)

Registrant - DERMARITE INDUSTRIES, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DERMARITE INDUSTRIES LLC		883925562	manufacture(61924-106)