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NDC 61924-0106-04 GELRITE 65 mL/100mL Details

GELRITE 65 mL/100mL

GELRITE is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by DERMARITE INDUSTRIES, LLC. The primary component is ALCOHOL.

Product Information

NDC	61924-0106
Product ID	61924-106_d57d3812-9482-56a6-e053-2a95a90aaa82
Associated GPIs	90971501300940
GCN Sequence Number	053800
GCN Sequence Number Description	ethyl alcohol GEL (ML) 65 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	21547
HICL Sequence Number	001681
HICL Sequence Number Description	ETHYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	GELRITE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hand Sanitizer
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	65
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	DERMARITE INDUSTRIES, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61924-0106-04 (61924010604)

Pricing Information	N/A
NDC Package Code	61924-106-04
Billing NDC	61924010604
Package	118 mL in 1 BOTTLE, DISPENSING (61924-106-04)
Marketing Start Date	2006-04-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4180193e-9d34-2ecf-e054-00144ff88e88 Details

Active Ingredient

Alcohol 65%

Purpose

Skin Protectant

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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

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

Labeler - DERMARITE INDUSTRIES, LLC (883925562)

Registrant - DERMARITE INDUSTRIES, LLC (883925562)

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

Revised: 1/2022

Document Id: d57d3812-9482-56a6-e053-2a95a90aaa82

Set id: 4180193e-9d34-2ecf-e054-00144ff88e88

Version: 8

Effective Time: 20220113

Search by Drug Name or NDC

NDC 61924-0106-04 GELRITE 65 mL/100mL Details

GELRITE 65 mL/100mL

Product Information

Package

Package Images

NDC 61924-0106-04 (61924010604)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4180193e-9d34-2ecf-e054-00144ff88e88 Details

Active Ingredient

Purpose

Uses

Warnings

Directions

Other Information

Inactive ingredients

Questions?

Keep out of reach of children

GelRite Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

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Search by Drug Name or NDC

NDC 61924-0106-04 GELRITE 65 mL/100mL Details

GELRITE 65 mL/100mL

Product Information

Package

Package Images

NDC 61924-0106-04 (61924010604)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4180193e-9d34-2ecf-e054-00144ff88e88 Details

Active Ingredient

​ Purpose

​Uses

​Warnings

Directions

Other Information

​Inactive ingredients

Questions?

Keep out of reach of children

GelRite Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

Purpose

Uses

Warnings

Inactive ingredients