NDC 77216-003 Maple Cross 75 Isopropyl Antibacterial

Isopropyl Alcohol

NDC Product Code 77216-003

NDC 77216-003-01

Package Description: 50 PATCH in 1 CANISTER > 3 mL in 1 PATCH

NDC 77216-003-02

Package Description: 100 PATCH in 1 CANISTER > 3 mL in 1 PATCH

NDC Product Information

Maple Cross 75 Isopropyl Antibacterial with NDC 77216-003 is a a human over the counter drug product labeled by Maple Cross Health Inc.. The generic name of Maple Cross 75 Isopropyl Antibacterial is isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Maple Cross Health Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Maple Cross 75 Isopropyl Antibacterial 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.

  • ISOPROPYL ALCOHOL .75 mL/mL

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.

  • 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: Maple Cross Health Inc.
Labeler Code: 77216
FDA Application Number: part333E 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: 07-15-2020 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.

Maple Cross 75 Isopropyl Antibacterial Product Label Images

Maple Cross 75 Isopropyl Antibacterial 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

Medicinal / Active Ingredient:

Isopropyl alcohol 75% v/v

Purpose:

Antiseptic

Non Medicinal / Inactive Ingredients:

Water (Aqua). This product does not contain mercury.

Indications:

Medicated (skin) cleanser. Effective in destroying (harmful) bacteria to provide 
antiseptic cleansing.

Directions:

Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

Warning:

Flammability warning. Keep away from open flame and sources of heat. For external use only.

Keep Out Of Reach Of Children.

If swallowed, call a poison control centre or get medical help right away.

Stop Use And Ask/ Consult A Doctor

Physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

When Using This Product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Contraindications:

Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional).

Other Information:

Store below 110°F (43°C). May discolour certain fabrics or surfaces.

* Please review the disclaimer below.