INTERNATIONAL HARBOR- alcohol gel

International Harbor by

Drug Labeling and Warnings

International Harbor by is a Otc medication manufactured, distributed, or labeled by INTERNATIONAL HARBOR LLC, Octapod, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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 or 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 water.
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. 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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water, glycerin, carbomer, triethanolamine.

PRINCIPAL DISPLAY PANEL

PDP 60 ml NDC: 79838-003-01

PDP 250 ml NDC: 79838-003-02

PDP 500 ml NDC: 79838-003-03

PDP 1000 ml NDC: 79838-003-04

PDP 1800 ml NDC: 79838-003-05

PDP 3785 ml NDC: 79838-003-06

INGREDIENTS AND APPEARANCE

INTERNATIONAL HARBOR 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79838-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36)	0.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	23.425 mL  in 100 mL
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)	0.125 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79838-003-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79838-003-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 79838-003-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 79838-003-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 79838-003-05	1800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 79838-003-06	3785 mL in 1 BOTTLE; 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 - INTERNATIONAL HARBOR LLC (117485044)

Registrant - INTERNATIONAL HARBOR LLC (117485044)

Establishment
Name	Address	ID/FEI	Business Operations
INTERNATIONAL HARBOR LLC		117485044	label(79838-003)

Establishment
Name	Address	ID/FEI	Business Operations
Octapod, S.A. de C.V.		951578993	manufacture(79838-003)