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Hygiene clean pumpkin spice hand sanitizer - Medication Information

Product NDC Code 80499-008
Drug Name

Hygiene clean pumpkin spice hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1049254
Application Number 505G(a)(3)
Labeler Name USA Broom LLC
Packages
Package NDC Code Description
80499-008-01 50 ml in 1 bottle (80499-008-01)
80499-008-02 24 bottle in 1 box (80499-008-02) / 50 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Benzalkonium Chloride 0.13% Purpose Antimicrobial

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 Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together briskly until dry

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: Water; Propylene Glycol; Lauramine Oxide; Undeceth-7; Disodium EDTA; Aloe Barbadensis Gel; Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

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 For hand sanitizing to decrease the bacteria on skin. Recommended for repeated use.

Purpose

Information about the drug product’s indications for use.
Purpose Antimicrobial

Spl product data elements

Usually a list of ingredients in a drug product.
Hygiene Clean Pumpkin Spice Hand Sanitizer BENZALKONIUM CHLORIDE WATER PROPYLENE GLYCOL LAURAMINE OXIDE UNDECETH-7 EDETATE DISODIUM ANHYDROUS ALOE VERA LEAF GLYCERETH-2 COCOATE DMDM HYDANTOIN CITRIC ACID MONOHYDRATE BENZALKONIUM CHLORIDE BENZALKONIUM

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 Labeling:50ml Bottle Package Labeling:50ml (24 Bottles) Bottle2

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

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.

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 redness develops, or if condition persists for more than 72 hours.

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 avoid contact with eyes. 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 When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. 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