NDC 70848-413 Acqua Aroma Hand Sanitizer Gel

Alcohol

NDC Product Code 70848-413

NDC 70848-413-80

Package Description: 380 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Acqua Aroma Hand Sanitizer Gel with NDC 70848-413 is a a human over the counter drug product labeled by Smell It Industria E Comercio Ltda. The generic name of Acqua Aroma Hand Sanitizer Gel is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Smell It Industria E Comercio Ltda

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Acqua Aroma Hand Sanitizer Gel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 266.304 mL/380mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

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

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Smell It Industria E Comercio Ltda
Labeler Code: 70848
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acqua Aroma Hand Sanitizer Gel Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Purpose:

Purpose: Antiseptic

Use

Decreases
bacteria on hands.

Warnings

Flammable. Keep away from flame or high heat.
For external use only.

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

(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.

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.

(For 1.0 Fl Oz) Warnings

Keep out reach of Children. 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.

(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

* Please review the disclaimer below.