NDC 90052-101 Laevia Hand Sanitizer

Alcohol

NDC Product Code 90052-101

NDC 90052-101-01

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Laevia Hand Sanitizer with NDC 90052-101 is a a human over the counter drug product labeled by Salvatori Industria E Comercio De Cosmeticos Ltda. The generic name of Laevia Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Salvatori Industria E Comercio De Cosmeticos 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.

Laevia Hand Sanitizer 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 70 mL/100mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

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.
  • 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: Salvatori Industria E Comercio De Cosmeticos Ltda
Labeler Code: 90052
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: 09-29-2020 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.

Laevia Hand Sanitizer Product Label Images

Laevia Hand Sanitizer 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

Other

  • This hand sanitizer is manufactured using the following ingredients:Alcohol (ethanol) (70%, volume/volume (v/v)GlycerolAminomethylpropanolCarbomer Interpolymer Type A 55000 CPSDenatonium BenzoateSterile distilled water or boiled cold water.The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from fire or flame

Use

• To decrease bacteria on the skin that could cause disease• recommended for repeated use.

Do Not Use

On children less than 2 months of age

When Using This Product

When using this product:• avoid contact with eyes, ears, and mouth. If contact occurs, flush thoroughly with water• avoid contact with broken skin

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.• keep out of reach of pets

Directions

• Apply a small portion on your hands, rub well and allow to dry without wiping• Use only as directed.

Other Information

• Store between 59-86°F• Avoid freezing and excessive heat above 104°F• May discolor certain fabrics or surfaces

Inactive Ingredients

Water (Aqua), Glycerin, Aminomethylpropanol, Carbomer Interpolymer Type A (55000 CPS), Denatonium Benzoate

* Please review the disclaimer below.