Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Inactive ingredients

Allantoin
Ultra Pure Water
Silver

Use

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

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

in children less than 2 months of age
on open skin wounds

Directions

Dosage: 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.

Package Label - Principal Display Panel

125 ml NDC: 79930-7106-1

500 ml NDC: 79930-7106-4

125 ml NDC: 79930-7107-1 Lavender Citrus

500 ml NDC: 79930-7107-4 Lavender Citrus

100 ml NDC: 79930-7110-1 WM Brown LMP

125ml herbal ADG ISO 500ml Herbal ISO ADG Back 500ml Herbal ISO ADG Front 125 LC 4oz ISO label 500 LC ISO label Back 500 LC ISO label Front

100 ml WMxADG

WM BROWN X ACQUA DI GABRIEL
hand sanitizing mist lmp spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79930-7110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)	0.03 mL in 100 mL
SILVER (UNII: 3M4G523W1G)	0.5 mL in 100 mL
WATER (UNII: 059QF0KO0R)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
LEMON OIL (UNII: I9GRO824LL)
MANDARIN OIL (UNII: NJO720F72R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79930-7110-1	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020

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

ACQUA DI GABRIAL
hand sanitizing mist lc spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79930-7107
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79930-7107-1	125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020
2	NDC:79930-7107-4	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020

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

ACQUA DI GABRIAL
hand sanitizing mist herbal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79930-7106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79930-7106-1	125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020
2	NDC:79930-7106-4	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2020

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

Labeler - Nexderma (079533940)

Name	Address	ID/FEI	Business Operations
Establishment
Nexderma		079533940	manufacture(79930-7106, 79930-7107, 79930-7110) , pack(79930-7106, 79930-7107, 79930-7110) , label(79930-7106, 79930-7107, 79930-7110)

Acqua Di Gabriel ISO Version