BLUTIZER HAND SANITIZER GEL- alcohol solution, gel forming, extended release

Blutizer Hand Sanitizer Gel by

Drug Labeling and Warnings

Blutizer Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by CampusORG Turizm Organizasyon Reklamcilik Pazarlama Sanayi ve Ticaret Limited Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol %70 (%96,4 volume) v/v Purpose: Antiseptic

Purpose

Antiseptic: Hand Sanitizer

USE IN SPECIFIC POPULATIONS

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat of flame.

Do Not Use

in children less than 2 months of age.

on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with warter.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious contiditon.

Keep our of reac of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surfaces. Rub hand together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

Store between 15-43C (59-110F)

Avoid freezing and excessive heat above 43C (110F)

INACTIVE INGREDIENT

• Isopropyl Alcohol %3 (Purpose: Antiseptic and Anti-Foaming)
• Glycerin (Purpose: Humidifier)
• Hydrogen Peroxide (Purpose: Sterilizing)
• Propylene Glycol
• Isopropyl Myristate
• Trolamine
• Carbomer
• Prufied Water USP (Purpose: Solvent)

PRINCIPAL DISPLAY PANEL

1000 mL (33 fl oz) NDC: 77184-135-11

INGREDIENTS AND APPEARANCE

BLUTIZER HAND SANITIZER GEL 
alcohol solution, gel forming, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77184-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.1 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.02 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	3 mL  in 100 mL
CARBOMER 980 (UNII: 4Q93RCW27E)	0.28 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.28 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77184-135-11	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77184-135-12	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 77184-135-13	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC: 77184-135-14	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
5	NDC: 77184-135-15	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
6	NDC: 77184-135-16	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
7	NDC: 77184-135-17	35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
8	NDC: 77184-135-19	5000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
9	NDC: 77184-135-20	10000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
10	NDC: 77184-135-21	3 mL in 1 PACKET; Type 0: Not a Combination Product	03/30/2020
11	NDC: 77184-135-22	5 mL in 1 PACKET; Type 0: Not a Combination Product	03/30/2020
12	NDC: 77184-135-23	7 mL in 1 PACKET; Type 0: Not a Combination Product	03/30/2020
13	NDC: 77184-135-24	10 mL in 1 PACKET; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - CampusORG Turizm Organizasyon Reklamcilik Pazarlama Sanayi ve Ticaret Limited Sirketi (519903395)

Registrant - CampusORG Turizm Organizasyon Reklamcilik Pazarlama Sanayi ve Ticaret Limited Sirketi (519903395)

Establishment
Name	Address	ID/FEI	Business Operations
CampusORG Turizm Organizasyon Reklamcilik Pazarlama Sanayi ve Ticaret Limited Sirketi		519903395	manufacture(77184-135) , relabel(77184-135) , label(77184-135)