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DRUG FACTS
Recovery Antiseptic Skin Prep Lotion
FDA Label NDC 49436-377
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Purklenz Formulations Inc. for the product Recovery Antiseptic Skin Prep (NDC 49436-377). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
RECOVERY
ANTISEPTIC
SKIN PREP
VEGAN-FRIENDLY
FREE OF ALCOHOL, PARABENS,
FRAGRANCES & DYES
30 FL. OZ. (900 mL)
NDC: 49436-377-30
recoveryaftercare.com
@recoveryaftercare
Distributed by
Recovery Aftercare, Inc.
Hanover, MD 21076
Made in Canada
©Recovery Aftercare, Inc. 2020
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