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Natural concepts alcohol-free hand sanitizer - Medication Information

Product NDC Code 63148-512
Drug Name

Natural concepts alcohol-free hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1098199
Application Number part333E
Labeler Name Apollo Health and Beauty Care Inc.
Packages
Package NDC Code Description
63148-512-02 59 ml in 1 bottle, plastic (63148-512-02)
63148-512-08 236 ml in 1 bottle, plastic (63148-512-08)
63148-512-32 946 ml in 1 bottle, plastic (63148-512-32)
63148-512-03 59 ml in 1 bottle, plastic (63148-512-03)
63148-512-09 236 ml in 1 bottle, plastic (63148-512-09)
63148-512-33 946 ml in 1 bottle, plastic (63148-512-33)
63148-512-04 59 ml in 1 bottle, plastic (63148-512-04)
63148-512-10 236 ml in 1 bottle, plastic (63148-512-10)
63148-512-34 946 ml in 1 bottle, plastic (63148-512-34)
63148-512-37 3785 ml in 1 package (63148-512-37)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium Chloride 0.13% 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.
Directions put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry. children under 6 years should be supervised when using this product.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

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 to help reduce bacteria on the skin. For use when soap and water are not available.

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.
Natural Concepts Alcohol-Free Hand Sanitizer Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) EDETATE SODIUM CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE DMDM HYDANTOIN

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.
Label copy image of the label

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 on children less than 2 months of age on open skin wounds Stop use and ask a doctor if irritation develops Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away.

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, call a Poison Control Center or get medical help right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-866-695-3030

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 develops Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away.

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. If contact occurs, rinse eyes thoroughly with water. Do not use on children less than 2 months of age on open skin wounds Stop use and ask a doctor if irritation develops Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away.

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. If contact occurs, rinse eyes thoroughly with water. Do not use on children less than 2 months of age on open skin wounds Stop use and ask a doctor if irritation develops Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help 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