NDC 77573-003 Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free

Alcohol

NDC Product Code 77573-003

NDC CODE: 77573-003

Proprietary Name: Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 77573 - Jiangsu Aimeili Cosmetic Co.,ltd.
    • 77573-003 - Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free

NDC 77573-003-01

Package Description: 3785 mL in 1 BOTTLE

NDC Product Information

Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free with NDC 77573-003 is a a human over the counter drug product labeled by Jiangsu Aimeili Cosmetic Co.,ltd.. The generic name of Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free is alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Jiangsu Aimeili Cosmetic Co.,ltd.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free 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.

  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • GLYCEROL FORMAL (UNII: 3L7GR2604E)
  • ALOE (UNII: V5VD430YW9)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Jiangsu Aimeili Cosmetic Co.,ltd.
Labeler Code: 77573
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: 08-25-2020 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.

Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free Product Label Images

Terra Pure Spa Collection Fresh Aloe Hand Sanitizer Paraben And Gluten Free 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

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

To reduce bacteria that potentially can cause diseaseRecommended for repeated use

Warnings

For external use only -handsFlammable. Keep away from heat and flame

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.Do not useIn children less than 2 months of ageOn open sin wounds

Otc - Stop Use

Stop use and ask a doctor if irritation or redness 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.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.For children under 6, use only under adult supervision

Other Information

Store between 15-30C (59 to 86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, aloe extract, triethanolamine, glycerol, carbomer, vitamin E, Fragrance

* Please review the disclaimer below.