NDC 72197-028 Pharmacys Prescription Hand Sanitizer

Alcohol

NDC Product Code 72197-028

NDC 72197-028-05

Package Description: 147 mL in 1 BOTTLE

NDC 72197-028-16

Package Description: 473 mL in 1 BOTTLE, PUMP

NDC 72197-028-99

Package Description: 3785.41 mL in 1 BOTTLE

NDC Product Information

Pharmacys Prescription Hand Sanitizer with NDC 72197-028 is a a human over the counter drug product labeled by American Consumer Products Corp. The generic name of Pharmacys Prescription Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: American Consumer Products Corp

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.

Pharmacys Prescription 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 65 mL/100mL
  • ALCOHOL 65 mL/100mL
  • ALCOHOL 65 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.

  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • .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.
  • 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.
  • 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: American Consumer Products Corp
Labeler Code: 72197
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: 05-05-2020 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.

Pharmacys Prescription Hand Sanitizer Product Label Images

Pharmacys Prescription 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

Active Ingredient

Active Ingredients - Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

Uses - Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

Warnings - For external use only. Do not ingest or swallow.
Flammable. Keep away from fire or flame.Do not appy around eyes. Do not use in ears & mouth.

Otc - When Using

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop Use And Ask A Doctor

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions - pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Other Information

Other information - store at 20º C (68º to 77º F). May discolor fabrics.

Inactive Ingredient

INACTIVE INGREDIENTS: Purified Water (Aqua), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis (Aloe Vera) Leaf Juice

* Please review the disclaimer below.