NDC 52862-025 Isopropyl Rubbing Alcohol 70% With Wintergreen

Isopropyl Alcohol

NDC Product Code 52862-025

NDC 52862-025-03

Package Description: 119 mL in 1 BOTTLE, PLASTIC

NDC 52862-025-04

Package Description: 178 mL in 1 BOTTLE, PLASTIC

NDC 52862-025-06

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 52862-025-09

Package Description: 295 mL in 1 BOTTLE, PLASTIC

NDC 52862-025-10

Package Description: 354 mL in 1 BOTTLE, PLASTIC

NDC 52862-025-11

Package Description: 414 mL in 1 BOTTLE, PLASTIC

NDC 52862-025-12

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Isopropyl Rubbing Alcohol 70% With Wintergreen with NDC 52862-025 is a a human over the counter drug product labeled by Home Smart Products. 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)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • 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: Home Smart Products
Labeler Code: 52862
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: 06-18-2020 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 ingredient (by volume)Isopropyl alcohol (70% concentrate)

Otc - Purpose

Purposetopical antimicrobial

Indications & Usage

  • Usesto decrease germs in minor cuts and scrapeshelps relieve minor muscular aches due to exertion

Warnings

  • WarningsFor external use onlyflammable, keep away from fire and flamewill produce serious gastric disturbances if taken internally

Otc - Ask Doctor

Ask a doctor before use if you have deep puncture wounds or serious burns

Otc - Do Not Use

  • When using this productdo not get into eyes or mucous membranesuse only in a well-ventilated area

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.In case of an accidental ingestion, contact a Poison Control Center immediately

Dosage & Administration

  • Directionsapply to skin directly of with clean gauze, cotton or swabfor rubbing apply liberally and rub with hands

Other

  • Other informationdoes not contain, nor is intended as a substitute for grain or ethyl alcoholkeep bottle tightly closed

PRINCIPAL DISPLAY PANELHEALTH SMART ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREENTOPICAL ANTIMICROBIAL12 FL.OZ (354 mL)

Inactive Ingredient

Inactive ingredientWater, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

* Please review the disclaimer below.