ACQUA AROMA HAND SANITIZER GEL- alcohol gel

Acqua Aroma Hand Sanitizer Gel by

Drug Labeling and Warnings

Acqua Aroma Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Smell It Industria e Comercio Ltda, Acqua Aroma US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose:

Purpose: Antiseptic

Use

Decreases 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?

(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

INGREDIENTS AND APPEARANCE

ACQUA AROMA HAND SANITIZER GEL 
alcohol gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Smell It Industria e Comercio Ltda (678349245)

Registrant - Acqua Aroma US LLC (080193028)

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