NDC 52000-053 Isopropyl Rubbing Alcohol 70% With Wintergreen

Isopropyl Alcohol

NDC Product Code 52000-053

NDC 52000-053-01

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 52000-053-02

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC 52000-053-03

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 52000-053-04

Package Description: 296 mL in 1 BOTTLE, PLASTIC

NDC 52000-053-05

Package Description: 355 mL in 1 BOTTLE, PLASTIC

NDC 52000-053-06

Package Description: 414 mL in 1 BOTTLE, PLASTIC

NDC 52000-053-07

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Isopropyl Rubbing Alcohol 70% With Wintergreen with NDC 52000-053 is a a human over the counter drug product labeled by Universal Distribution Center Llc. The generic name of Isopropyl Rubbing Alcohol 70% With Wintergreen is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 808520.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Isopropyl Rubbing Alcohol 70% With Wintergreen 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)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Universal Distribution Center Llc
Labeler Code: 52000
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: 05-20-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Isopropyl Rubbing Alcohol 70% With Wintergreen Product Label Images

Isopropyl Rubbing Alcohol 70% With Wintergreen 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

Active Ingredients (by volume)Isopropyl alcohol (70% conc.)

Otc - Purpose

PurposeFirst aid antiseptic

Indications & Usage

  • Usesfirst aid to help prevent the risk of infection in minor cuts, scrapes and burns


WarningsFor external use only; flammable, keep away from fire or flame, heat, spark, electrical

Otc - Ask Doctor

  • Ask a doctor before use if you havedeep punctured wounds, animal bites or serious burns

Otc - When Using

  • When using this productdo not get into eyesdo not apply over large areas of the bodydo not use longer than one week unless directed by a doctor

Otc - Stop Use

  • Stop using this product ifcondition persists or gets worse

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of childrenIn case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

Dosage & Administration

  • Directionsclean effected areaapply small amount of this product on the area 1-3 times dailymay be covered with a sterile bandageif bandaged, let dry first


  • Other informationstore at room temperaturedoes not contain, nor is intended as a substitute for grain or ethyl alcoholwill produce serious gastric disturbances if taken internally

Inactive Ingredient

Inactive IngredientsWater(Aqua), Methyl Salicylate, FD&C Blue #1, FD&C Yellow #5

* Please review the disclaimer below.