NDC 77529-002 Myremede 75% Alcohol Wipes

Alcohol

NDC Product Code 77529-002

NDC 77529-002-60

Package Description: 60 PATCH in 1 TUBE, WITH APPLICATOR > 3.265 mL in 1 PATCH

NDC Product Information

Myremede 75% Alcohol Wipes with NDC 77529-002 is a a human over the counter drug product labeled by Remede Organics, Inc.. The generic name of Myremede 75% Alcohol Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Remede Organics, 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.

Myremede 75% Alcohol Wipes 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 .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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Remede Organics, Inc.
Labeler Code: 77529
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: 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.

Myremede 75% Alcohol Wipes Product Label Images

Myremede 75% Alcohol Wipes 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

Ethanol 75% v/v

Purpose

Antiseptic

Use

Alcohol wipes designed to help reduce bacteria when soap and water are not available or practical.

Warnings

For external use only. Flammable. Keep away from heat or flame.For single and non-medical use only. Appropriately dispose of used wipes.

Do Not Use

  • In children less than 2 months of age on open skin wounds

When Using This Product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Consult A Doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If ingested, get medical help or contact a Poison Control Center right away.

Directions

  • Apply topically as needed to intended surfaces. Let air dry.Supervise children under 6 years of age when using this product to avoid choking.Do not flush wipes

Other Information

  • Store in a dry place between 1-490C (50-1200F)Avoid freezing and excessive heat 490C (1200F)

Inactive Ingredients

Pure water, glycerol, aloe vera gel

* Please review the disclaimer below.