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Xs alcohol prep pad saturated with 70% alcohol - Prescription Drug Labeling

Product NDC Code 43116-023
Drug Name

Xs alcohol prep pad saturated with 70% alcohol

Type Generic
Active Ingredients
Alcohol 70 ml/1001
Route TOPICAL
Dosage Form CLOTH
Application Number part333A
Labeler Name Shenzhen Shierjie Biological Engineering Co., LTD
Packages
Package NDC Code Description
43116-023-01 1 cloth in 1 pouch (43116-023-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient alcohol70%

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 Children under 6 years of age should be supervised when using this product

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water(Aqua), Non-woven

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 It is mainly used for cleaning and disinfecting skin and appliances

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.
XS Alcohol Prep Pad Saturated with 70% alcohol XS Alcohol Prep Pad Saturated with 70% alcohol 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 43116-022-01 1P

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.
When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with 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 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 doctor if irritation or rash appears and lasts.

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, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask doctor if irritation or rash appears and lasts. keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store below110°F(43℃) May discolor certain fabrics or surfaces Don 't put it in the car, keep away from high temperature

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 or flame For external use only. When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask doctor if irritation or rash appears and lasts. 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 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