Drug Facts

Active Ingredient: Ethyl Alcohol 70% v/v

Purpose:

Purpose: Antiseptic

Use

Decreases Use bacteria on hands.

Warnings

Flammable. Keep away from flame or high heat. 

For external use only. 

(For 1.0 FL OZ) Warnings:

When using this product avoid contact with eyes.

(For 12.9 FL OZ) Warnings:

When using this product avoid contact with eyes. If contact occurs, rinse with water. 

Warnings

Stop use and ask a doctor if irritation and redness develop or increase. 

(For 1.0 FL OZ) Warnings

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

(For 12.9 FL OZ) Warnings:

Keep out reach of Children. Children under 6 year old should be supervised when using it. If swallowed, get medical help or contact a Poison Control Center right away.

Other Information:

Store below 104°F (40°C). May discolor certain fabrics or surfaces.

Directions

Rub into hands until dry.

(For 1.0 FL OZ) Inactive Ingredients:

Inactive ingredients: Water (Aqua), Methyl Gluceth-20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aminomethyl Propanol, Mannitol, Cellulose, Citronellol, Linalool, Alpha-isomethyl Ionone, Coumarin, CI 77492, D-limonene, Geraniol, Tocopheryl Acetate, Hydroxypropyl Methylcellulose.

(For 12.9 FL OZ) Inactive Ingredients:

Inactive Ingredients: Water (Aqua), Acrylates C10-30 Alkyl Acrylate Crosspolymer, Methyl Gluceth-20, Fragrance (Parfum), Aminomethyl Propanol, Mannitol, Cellulose, Citronellol, Linalool, Alpha-isomethyl Ionone, Acrylates Copolymer, Coumarin, CI 77492, Hydroxypropylcellulose, Mica, CI 77891, D-limonene, Geraniol, Hydroxypropyl Methylcellulose, Triethyl Citrate, Acrylate Ammonium Methacrylate Copolymer, CI 77491, Caprylyl Capryl Glucoside, Caprylic Capric Triglyceride, Lauryl Glucoside, Talc, Tocopheryl Acetate.

Questions

Questions: 1-844-636-7504 | CustomerService@acquaaroma.com

(For 1.0 OZ) Primary Panel

NDC Number Acqua Aroma With Vitamin E microspheres Hand Sanitizer Gel 1.0 FL OZ (30ML) Kills 99.9% of common bacteria

(For 12.9 OZ) Primary Panel

Acqua Aroma The Scent of Your Home NDC Number With Vitamin E microspheres Hand Sanitizer Gel 12.9 FL OZ (380ML) Kills 99.9% of common bacteria

ACQUA AROMA HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70848-410
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	21.024 mL in 30 mL

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.0315 mL in 30 mL
POWDERED CELLULOSE (UNII: SMD1X3XO9M)	0.009 mL in 30 mL
MANNITOL (UNII: 3OWL53L36A)	0.0138 mL in 30 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.00024 mL in 30 mL
WATER (UNII: 059QF0KO0R)	8.6655 mL in 30 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.09 mL in 30 mL
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	0.09 mL in 30 mL
HYPROMELLOSES (UNII: 3NXW29V3WO)	0.00024 mL in 30 mL
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	0.00072 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70848-410-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/2016

ACQUA AROMA HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70848-413
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	266.304 mL in 380 mL

Ingredient Name	Strength
Inactive Ingredients
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)	0.00304 mL in 380 mL
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)	0.02546 mL in 380 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	0.00304 mL in 380 mL
TALC (UNII: 7SEV7J4R1U)	0.00304 mL in 380 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.399 mL in 380 mL
POWDERED CELLULOSE (UNII: SMD1X3XO9M)	0.1824 mL in 380 mL
MANNITOL (UNII: 3OWL53L36A)	0.361 mL in 380 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.00304 mL in 380 mL
WATER (UNII: 059QF0KO0R)	109.421 mL in 380 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	1.14 mL in 380 mL
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	1.14 mL in 380 mL
HYPROMELLOSES (UNII: 3NXW29V3WO)	0.00608 mL in 380 mL
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	0.01216 mL in 380 mL
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)	0.00304 mL in 380 mL
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.00304 mL in 380 mL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)	0.01216 mL in 380 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.01026 mL in 380 mL
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)	0.00304 mL in 380 mL
MICA (UNII: V8A1AW0880)	0.01216 mL in 380 mL
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)	0.00304 mL in 380 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70848-413-80	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/2016

Labeler - Smell It Industria e Comercio Ltda (678349245)

Registrant - Acqua Aroma US LLC (080193028)

Name	Address	ID/FEI	Business Operations
Establishment
Smell It Industria e Comercio Ltda		678349245	manufacture(70848-410, 70848-413)