GELRITE

Main information

  • Trade name:
  • GELRITE- hand sanitizer gel
  • Composition:
  • ALCOHOL 65 mL in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GELRITE- hand sanitizer gel
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Antiseptic - For handwashing to decrease bacteria on skin. - Recommended for repeated use.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 61924-106-04, 61924-106-16, 61924-106-27, 61924-106-34
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

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

Antiseptic

Us es

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

Ques tions ?

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

Keep out of reach of children

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

GELRITE

hand sanitizer gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 24-10 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 5 mL in 10 0 mL

Inactive Ingredients

DERMARITE INDUSTRIES, LLC

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)

DENATO NIUM BENZO ATE ANHYDRO US (UNII: M5BA6 GAF1O)

PRO PYLENE GLYCO L 1,2 -DISTEARATE (UNII: T6 5PN3O37H)

BUTANO L ( MIXED ISO MERS) (UNII: WB0 9 NY8 3YA)

2 ,4 ,5-T-TRO LAMINE (UNII: 9 0 0 7L1DAXM)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SO DIUM ISO STEARO YL LACTYLATE (UNII: 8 730 J0 D3EV)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 19 24-10 6 -

118 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/25/20 0 6

2

NDC:6 19 24-10 6 -

473 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 0 6

3

NDC:6 19 24-10 6 -

8 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 0 6

4

NDC:6 19 24-10 6 -

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 0 6

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 4/25/20 0 6

Labeler -

DERMARIT E INDUST RIES, LLC (883925562)

Registrant -

DERMARIT E INDUST RIES, LLC (883925562)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

DERMARITE INDUSTRIES LLC

8 8 39 2556 2

ma nufa c ture (6 19 24-10 6 )

Revised: 4/2018