Label: ACQUA AROMA HAND SANITIZER GEL- alcohol gel

  • NDC Code(s): 70848-410-30, 70848-413-80
  • Packager: Smell It Industria e Comercio Ltda
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated June 6, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredient: Ethyl Alcohol 70% v/v

  • Purpose:

    Purpose: Antiseptic

  • Use

    Decreases Usebacteria 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

    Acqua AromaNDC 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 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:70848-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL21.024 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70848-410-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2016
    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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL266.304 mL  in 380 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70848-413-80380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2016
    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/FEIBusiness Operations
    Smell It Industria e Comercio Ltda678349245manufacture(70848-410, 70848-413)