NDC 49953-1801 Alcohol Swabstick - Antiseptic

Isopropyl Alcohol

NDC Product Code 49953-1801

NDC 49953-1801-1

Package Description: 7.8 mL in 1 BAG

NDC 49953-1801-2

Package Description: 1.8 mL in 1 BAG

NDC Product Information

Alcohol Swabstick - Antiseptic with NDC 49953-1801 is a a human over the counter drug product labeled by Dalian Rongbang Medical Healthy Devices Co., Ltd.. The generic name of Alcohol Swabstick - Antiseptic is isopropyl alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Dalian Rongbang Medical Healthy Devices Co., Ltd.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Alcohol Swabstick - 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.

  • ISOPROPYL ALCOHOL .7 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: Dalian Rongbang Medical Healthy Devices Co., Ltd.
Labeler Code: 49953
FDA Application Number: part344 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-27-2020 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.

Alcohol Swabstick - Antiseptic Product Label Images

Alcohol Swabstick - 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

Otc - Active Ingredient

70% Isopropyl Alcohol

Otc - Purpose

Antiseptic

Use

  • For preparation of the skin prior to an injection

Warnings

  • For external use onlyFlammable, keep away from fire or flame

Otc - Do Not Use

  • Do not usewith electrocautery proceduresin the eyes

Otc - Stop Use

  • Discontinue useif irritation and redness developsStop use and consult a doctorif the condition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wipe injection site vigorously and discard

Other Information

  • Store at room temperature: 15
  • O-30
  • O C (59
  • O-86
  • O F)

Inactive Ingredient

Water

* Please review the disclaimer below.