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Smartowel wipes - Medication Information

Product NDC Code 84215-003
Drug Name

Smartowel wipes

Type Brand
Pharm Class Decreased Cell Wall Integrity [PE]
Active Ingredients
Benzalkonium chloride .1 g/1001
Chlorhexidine gluconate .1 g/1001
Route TOPICAL
Dosage Form CLOTH
Application Number M005
Labeler Name Freshening Paper Products(Hui Zhou)Co.Ltd
Packages
Package NDC Code Description
84215-003-01 40 cloth in 1 bag (84215-003-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Chlorhexidine digluconate :0.10% Benzalkonium chloride:0.10%

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 Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Purified water, Phenoxyethanol, Fragrance, Polysorbate 20, Aloe barbadensis Leaf Juice

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.
Use Be healthy, wipe before meals!

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Smartowel Wipes Wet Wipes POLYSORBATE 20 BENZALKONIUM CHLORIDE BENZALKONIUM WATER PHENOXYETHANOL CHLORHEXIDINE GLUCONATE CHLORHEXIDINE 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 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 in children less than 2 months of age

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.

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.

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.
If irritation occurs during use, please stop using immediately

Storage and handling

Information about safe storage and handling of the drug product.
Other information No data available

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

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