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| Product NDC Code | 82311-0118 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Biom sanitizing alcohol wipes - tea tree bliss |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SWAB | ||||||
| Labeler Name | Biom Innovations Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Alcohol 65% w/w. Purpose: Antiseptic
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.Dosage and Administration Ethanol 65%w/w. Wipe hands thoroughly. Discard after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Tea Tree Oil, Aloe Barbadensis Leaf Juice (Organic Aloe), Glycerin (Moisturizer)
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.Directions Wipe hands thoroughly. Discard after use.
Purpose
Information about the drug product’s indications for use.Purpose Reducing bacteria on skin.
Spl product data elements
Usually a list of ingredients in a drug product.biom Sanitizing Alcohol Wipes - Tea Tree Bliss ALCOHOL TEA TREE OIL GLYCERIN WATER ALCOHOL ALCOHOL ALOE VERA LEAF
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.Package Label - Principal Display Panel 10 wipes; NDC: 82311-0118-2, Hand Sanitizing Tea Tree Bliss Label - biom - Tea Tree Bliss 10 wipe packet
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.This is a hand sanitizer manufactured in compliance with (the now withdrawn) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: - Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%(w/w) or 70%(v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
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 Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately.
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 a doctor if redness or irritation develops and continues for more than 72 hours.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store below 104° F (40° C). Each wipe is 15 x 20 cm. May discolor certain fabrics. Do not use as a baby wipe, on the face, or in the genital area.
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 Flammable. Keep away from Fire and Flame. External Use Only. Do not use in eyes. If contact occurs, flush thoroughly with water. Stop use and ask doctor if redness or irritation develops and continues for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately. Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately.
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