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Acqua Aroma Hand Sanitizer Gel

Medically reviewed on Aug 27, 2018

Dosage form: gel
Ingredients: ALCOHOL 21.024mL in 30mL
Labeler: Smell It Industria e Comercio Ltda
NDC Code: 70848-410

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


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

ACQUA AROMA HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70848-410
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL21.024 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL0.0315 mL  in 30 mL
POWDERED CELLULOSE0.009 mL  in 30 mL
MANNITOL0.0138 mL  in 30 mL
.ALPHA.-TOCOPHEROL ACETATE0.00024 mL  in 30 mL
WATER8.6655 mL  in 30 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)0.09 mL  in 30 mL
METHYL GLUCETH-200.09 mL  in 30 mL
HYPROMELLOSES0.00024 mL  in 30 mL
FERRIC OXIDE YELLOW0.00072 mL  in 30 mL
Packaging
#Item CodePackage Description
1NDC:70848-410-3030 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2016
ACQUA AROMA HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70848-413
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL266.304 mL  in 380 mL
Inactive Ingredients
Ingredient NameStrength
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER0.00304 mL  in 380 mL
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER0.02546 mL  in 380 mL
MEDIUM-CHAIN TRIGLYCERIDES0.00304 mL  in 380 mL
TALC0.00304 mL  in 380 mL
AMINOMETHYLPROPANOL0.399 mL  in 380 mL
POWDERED CELLULOSE0.1824 mL  in 380 mL
MANNITOL0.361 mL  in 380 mL
.ALPHA.-TOCOPHEROL ACETATE0.00304 mL  in 380 mL
WATER109.421 mL  in 380 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)1.14 mL  in 380 mL
METHYL GLUCETH-201.14 mL  in 380 mL
HYPROMELLOSES0.00608 mL  in 380 mL
FERRIC OXIDE YELLOW0.01216 mL  in 380 mL
C12-20 ALKYL GLUCOSIDE0.00304 mL  in 380 mL
FERRIC OXIDE RED0.00304 mL  in 380 mL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED0.01216 mL  in 380 mL
TITANIUM DIOXIDE0.01026 mL  in 380 mL
LAURYL GLUCOSIDE0.00304 mL  in 380 mL
MICA0.01216 mL  in 380 mL
TRIETHYL CITRATE0.00304 mL  in 380 mL
Packaging
#Item CodePackage Description
1NDC:70848-413-80380 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2016
Labeler - Smell It Industria e Comercio Ltda (678349245)
Registrant - Acqua Aroma US LLC (080193028)
Establishment
NameAddressID/FEIOperations
Smell It Industria e Comercio Ltda678349245manufacture(70848-410, 70848-413)

 
Smell It Industria e Comercio Ltda

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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