NDC 79288-012 Safecare Premium Sanitizing Alcohol Wipes

Alcohol

NDC Product Code 79288-012

NDC 79288-012-01

Package Description: 50 PATCH in 1 BAG > 6.8 g in 1 PATCH

NDC 79288-012-02

Package Description: 100 PATCH in 1 DRUM > 6.2 g in 1 PATCH

NDC 79288-012-03

Package Description: 160 PATCH in 1 DRUM > 6.3 g in 1 PATCH

NDC Product Information

Safecare Premium Sanitizing Alcohol Wipes with NDC 79288-012 is a a human over the counter drug product labeled by Xiamen Yiukin Paper Products Co.,ltd. The generic name of Safecare Premium Sanitizing Alcohol Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Xiamen Yiukin Paper Products Co.,ltd

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.

Safecare Premium Sanitizing 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/100g

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Xiamen Yiukin Paper Products Co.,ltd
Labeler Code: 79288
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: 09-03-2020 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’.

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Safecare Premium Sanitizing Alcohol Wipes Product Label Images

Safecare Premium Sanitizing 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 Ingredients

Ethyl Alcohol 75%. Purpose: Antiseptic

Purpose

Antiseptic

Uses

  • For hand washng to decrease bacteria that potentially can cause disease.Antiseptic for hands and skin.Sanitize hands and skin when water and soap are not available.

Warnings

  • For external use only. DO NOT INGEST.Warning: Flammable. Do not use near open flame, fire or spark.

Do Not Use

On infants under 2 months old.On open skin or puncture-type wounds.Near or in eyes. If eye contact occurs, flush with cold water.

Otc - When Using

Supervise children under 6 years of age when using wipes.

Stop Using If Irritation Appears.

Seek medical attention if irritation persists.

Keep Out Of Reach Of Children

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

Directions For Use

  • Clean hands and skin with wipe by rubbing with wipe.No need to rinse, let hands or skin dry.

Other Information

  • Read all directions and warnings before using hand wipes.Store at room temperature 15 to 30 C (59 to 86 F) with package lid closed. Avoid excess heat above 40 C (104 F)

Inactive Ingredients

Water, Benzalkonium Chloride, Cetylpyridinium chloride, Phenoxyethanol, Propylene glycol

Any Questions?

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