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Biom sanitizing alcohol wipes - bergamot bloom - Medication Information

Product NDC Code 82311-0102
Drug Name

Biom sanitizing alcohol wipes - bergamot bloom

Type Brand
Active Ingredients
Alcohol 184.1 ml/263ml
Route TOPICAL
Dosage Form SWAB
Labeler Name Biom Innovations Inc
Packages
Package NDC Code Description
82311-0102-2 86 ml in 1 package (82311-0102-2)
82311-0102-1 263 ml in 1 package (82311-0102-1)
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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%. Wipe hands thoroughly. Discard after use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Citrus Bergamia Peel Oil (Bergamot Essential 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 - Bergamot Bloom ALCOHOL CITRUS AURANTIUM FRUIT RIND ALOE VERA LEAF GLYCERIN WATER ALCOHOL ALCOHOL

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: 82311-0102-2 biom08 labelling 2023

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.
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)) denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. - USP grade deionised water.

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 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 irritation or rash occurs. These may be signs of a serious condition.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store below 104° F (40° C). Each wipe is 19 x 22 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.

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