NDC 78495-162 Medi-first First Aid Antiseptic

Hydrogen Peroxide

NDC Product Code 78495-162

NDC 78495-162-01

Package Description: .0591 L in 1 BOTTLE, PUMP

NDC Product Information

Medi-first First Aid Antiseptic with NDC 78495-162 is a a human over the counter drug product labeled by Ultra Distributors Inc. The generic name of Medi-first First Aid Antiseptic is hydrogen peroxide. The product's dosage form is spray and is administered via topical form.

Labeler Name: Ultra Distributors Inc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Medi-first First Aid Antiseptic 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.

  • HYDROGEN PEROXIDE 30 mL/L

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ultra Distributors Inc
Labeler Code: 78495
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: 12-19-2020 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.

Medi-first First Aid Antiseptic Product Label Images

Medi-first First Aid Antiseptic 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

Hydrogen Peroxide 3.0%

Purpose

First aid antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do Not Use

  • Near eyes or mucous membraneson deep or puncture wounds, animal bites, or serious burns consult a doctoron large areas of the body

Stop Use And Ask A Doctor If

The condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Spray over a affected areaif bandaged, let dry firstnot to be used on children under 12 years of age

Inactive Ingredient

Purified water

Other

Treats minor cuts, scrapes and abrasionsHelps prevent infectionStore at 68°-77°F(20°-25°℃)

* Please review the disclaimer below.