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O well sanitizing hand wipes - Medication Information

Product NDC Code 77133-002
Drug Name

O well sanitizing hand wipes

Type Brand
Active Ingredients
Alcohol .75 ml/ml
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 1307051
Application Number 505G(a)(3)
Labeler Name ALCOVE BRANDS
Packages
Package NDC Code Description
77133-002-01 20 patch in 1 bag (77133-002-01) / 4 ml in 1 patch
77133-002-02 50 patch in 1 bag (77133-002-02) / 4 ml in 1 patch
77133-002-03 50 packet in 1 box (77133-002-03) / 1 patch in 1 packet / 3 ml in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Alcohol 75% Purpose Disinfection

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 Open the flip and tear the seal sticker Remove the wipes from the middle hole and use Close the flip to prevent the wipes from drying out

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aqua, Glycerin, Benzalkonium

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 Hand Sanitizer to help reduce bacteria on the skin

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
O Well sanitizing hand wipes ALCOHOL WATER GLYCERIN BENZALKONIUM 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 Labeling:20 Count Label Package Labeling:50 Count Label2 Package Labeling:50 individual packets Label3

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

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 or contact the eyes.

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 this out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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 These wipe do not replace wipe used for medical procedures. These wipes are meant for general cleansing. Keep in a dry place away from fire. Discontinue use if irritation and redness develop. If the condition persists for more than 72 hours, consult a physician. Please close the lid after dispending to maintain purity. Alcohol by nature evaporates quickly. Store below 95°F (35°C).

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. Do not use in or contact the eyes. When using this product These wipe do not replace wipe used for medical procedures. These wipes are meant for general cleansing. Keep in a dry place away from fire. Discontinue use if irritation and redness develop. If the condition persists for more than 72 hours, consult a physician. Please close the lid after dispending to maintain purity. Alcohol by nature evaporates quickly. Store below 95°F (35°C). Keep this out of reach of children. If swallowed, get medical help or contact a 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