NDC 75332-0008 Miracle Perfect Sanitizer Gel

Alcohol

NDC Product Code 75332-0008

NDC 75332-0008-1

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Miracle Perfect Sanitizer Gel with NDC 75332-0008 is a a human over the counter drug product labeled by Medicell Co.,ltd. The generic name of Miracle Perfect Sanitizer Gel is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Medicell Co.,ltd

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.

Miracle Perfect 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 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.

  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GRAPEFRUIT PEEL (UNII: 3582N05Q44)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • LEMON OIL (UNII: I9GRO824LL)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)

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: Medicell Co.,ltd
Labeler Code: 75332
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: 07-05-2020 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.

Miracle Perfect Sanitizer Gel Product Label Images

Miracle Perfect 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

Otc - Active Ingredient

Alcohol

Inactive Ingredient

Water

Glycerin

Carbomer

Aloe Extract

Green Tea Extract

Rosemary Extract

Grapefruit Extract

Tromethamine

Tea tree oil

Lemon Oil

Otc - Purpose

Sterilization of hands and skin

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Warnings

■ Flammable. Keep away from fire or flame.■ For external use only.■ Do not use in eyes.■ lf swallowed, get medical help promptly.■ Stop use, ask doctor lf irritation occurs.■ Keep out of reach of children.

Dosage & Administration

For external use only

* Please review the disclaimer below.