NDC 49436-377 Recovery Antiseptic Skin Prep

Chloroxylenol

NDC Product Code 49436-377

NDC 49436-377-30

Package Description: 900 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Recovery Antiseptic Skin Prep with NDC 49436-377 is a a human over the counter drug product labeled by Purklenz Formulations Inc.. The generic name of Recovery Antiseptic Skin Prep is chloroxylenol. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Purklenz Formulations Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Recovery Antiseptic Skin Prep 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.

  • CHLOROXYLENOL 3 g/100mL

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)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)

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: Purklenz Formulations Inc.
Labeler Code: 49436
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: 10-26-2020 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.

Recovery Antiseptic Skin Prep Product Label Images

Recovery Antiseptic Skin Prep 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

Other

DRUG FACTS

Otc - Active Ingredient

Active ingredient: Chloroxylenol 3%

Otc - Purpose

Purpose: Antiseptic

Indications & Usage

Uses: Antiseptic cleanser. Decreases harmful bacteria or germs.

Warnings

WARNINGS: FOR EXTERNAL USE ONLY. DO NOT INGEST.

Otc - When Using

When using this product: Do not use in or near the eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water.

Otc - Do Not Use

Do not use if: you are allergic or sensitive to any of the listed ingredients.

Otc - Stop Use

Stop use and ask doctor if: Irritation, rash, or other allergic reaction occurs.

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

Directions: Apply as needed and scrub thoroughly for at least 30 seconds. Rinse well and repeat. For best results, do not dilute.Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

Other Safety Information

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

Inactive Ingredient

Inactive ingredients: Water (aqua), Lauryl Glucoside, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Xanthan Gum, Citric Acid, Tetrasodium EDTA, Bis-Diglyceryl Polyacyladipate-2

Principal Display Package Labeling

RECOVERYANTISEPTICSKIN PREPVEGAN-FRIENDLYFREE OF ALCOHOL, PARABENS,FRAGRANCES & DYES30 FL. OZ. (900 mL)NDC: 49436-377-30recoveryaftercare.com@recoveryaftercareDistributed byRecovery Aftercare, Inc.Hanover, MD 21076Made in Canada©Recovery Aftercare, Inc. 2020res

* Please review the disclaimer below.