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Product NDC Code | 49436-377 | ||||
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Drug Name | Recovery antiseptic skin prep |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 413259 | ||||
Application Number | M003 | ||||
Labeler Name | PURKLENZ FORMULATIONS INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient : Chloroxylenol 3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water (aqua), Lauryl Glucoside, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Xanthan Gum, Citric Acid, Tetrasodium EDTA, Bis-Diglyceryl Polyacyladipate-2
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: Antiseptic cleanser. Decreases harmful bacteria or germs.
Purpose
Information about the drug product’s indications for use.Purpose: Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Recovery Antiseptic Skin Prep CHLOROXYLENOL CHLOROXYLENOL CHLOROXYLENOL WATER LAURYL GLUCOSIDE PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE PPG-2 HYDROXYETHYL COCAMIDE XANTHAN GUM CITRIC ACID MONOHYDRATE EDETATE SODIUM BIS-DIGLYCERYL POLYACYLADIPATE-2
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 res 49436-377 900mL
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if: you are allergic or sensitive to any of the listed ingredients.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if : Irritation, rash, or other allergic reaction occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: FOR EXTERNAL USE ONLY. DO NOT INGEST. 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. Do not use if: you are allergic or sensitive to any of the listed ingredients. Stop use and ask doctor if : Irritation, rash, or other allergic reaction occurs. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API