ACQUA DI GABRIEL- hand sanitizing mist spray

Acqua Di Gabriel by

Drug Labeling and Warnings

Acqua Di Gabriel by is a Otc medication manufactured, distributed, or labeled by Nexderma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 80%- Antiseptic to help reduce bacteria that potentially can cause disease

INACTIVE INGREDIENT

Allantoin

Ultra Pure Water

Silver

INDICATIONS & USAGE

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Apply Defense Ag on hands rubbing together until dried. Repeat as often as necessary.

KEEP OUT OF REACH OF CHILDREN

Adult supervision recommended for children under 6 years old.

WARNINGS

Keep away form fire and flame.

Flammable

For external use on hands only.

Keep out of eye, ears and mouth.

If contact in eyes, flush thoroughly with water.

Keep out of reach of children.

If swallowed seek medical help immediately or call your poison control center.

Store between 15-30 (58-86F)

Avoid freezing and excessive heat above 40C (104F)

Will damage wood finishes, plastics and some fabrics.

DO NOT USE

Children less than 2 months of age or on open wounds.

DOSAGE & ADMINISTRATION

Dosage: upto 10 times a day

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

Administration:Topoical

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACQUA DI GABRIEL 
hand sanitizing mist spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79930-7103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)	0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20 mL  in 100 mL
SILVER (UNII: 3M4G523W1G)	0.5 mL  in 100 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79930-7103-1	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020
2	NDC: 79930-7103-4	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/30/2020

Labeler - Nexderma Inc (079533940)

Establishment
Name	Address	ID/FEI	Business Operations
Nexderma Inc		079533940	manufacture(79930-7103) , pack(79930-7103) , label(79930-7103)