NDC 75349-002 Dermoviva First Aid Antiseptic

Isopropyl Alcohol

NDC Product Code 75349-002

NDC 75349-002-03

Package Description: 355 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dermoviva First Aid Antiseptic with NDC 75349-002 is a a human over the counter drug product labeled by Dabur International Limited. The generic name of Dermoviva First Aid Antiseptic is isopropyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Dabur International Limited

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Dermoviva 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.


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: Dabur International Limited
Labeler Code: 75349
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: 05-07-2020 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.

Dermoviva First Aid Antiseptic Product Label Images

Dermoviva 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


Drug Facts

Mfd. for Dabur International Ltd, Jebel Ali Free zone,Street No. N406, P.O. Box: 16944, Dubai, U.A.E.Country of Origin: United Arab Emirates.
For adverse event reporting: Dabur International Ltd.
5 Independence Way - Suite 300 / Office # 46 & 50Princeton, NJ 08540, Telephone: 609-514-5100NDC 75349-002-03

Otc - Active Ingredient

Active ingredientIsopropyl alcohol 70% v/v

Otc - Purpose

PurposeFirst aid antiseptic

Indications & Usage

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


For external use only.
Flammable. Keep away from fire or flame.

Otc - Do Not Use

  • Do not usein or near the eyesover large areas of the body

Otc - Ask Doctor

  • Ask a doctor before use if you havedeep or puncture woundsanimal bitesserious burns

Otc - When Using

When using this product do not use longer than one week unless directed by a doctor

Otc - Stop Use

Stop use and ask a doctor if condition persists or gets worse

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.

Dosage & Administration

  • Directionsclean the affected areaapply a small amount of this product onto the affected area 1 to 3 times dailymay be covered with a sterile bandage

Storage And Handling

  • Other informationstore between 15°-30°C (59°-86°F)avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredient

Inactive ingredientwater

* Please review the disclaimer below.