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Cleanze hand sanitizing - Medication Information

Product NDC Code 77720-016
Drug Name

Cleanze hand sanitizing

Type Brand
Active Ingredients
Alcohol 71 ml/100ml
Route TOPICAL
Dosage Form GEL
Application Number part333A
Labeler Name Skaffles Group Limited Liability Company
Packages
Package NDC Code Description
77720-016-01 500 ml in 1 bottle (77720-016-01)
77720-016-02 1000 ml in 1 bottle (77720-016-02)
77720-016-03 237 ml in 1 bottle (77720-016-03)
77720-016-04 60 ml in 1 bottle (77720-016-04)
77720-016-05 100 ml in 1 bottle (77720-016-05)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Ethyl Alcohol 71% 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 Directions . Pump a small amount in your palm and briskly rub hands together until dry. Children under 6 years of age should be supervised when in use. Other information . Store between 15 and 30C(59 and 86F).· Avoid freezing and excessive heat above 40C(104F).

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis Leaf Extract, Carbomer,Glycerin,Tocopheryl Acetate (Vitamin E), Triethanolamine, Water(Aqua).

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

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.
CLEANZE HAND SANITIZING ethyl alcohol GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALOE VERA LEAF WATER ALCOHOL ALCOHOL TROLAMINE ALPHA-TOCOPHEROL ACETATE

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.
1 2

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.

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.
Warning For external use only. Flammable. Keep away from fire or flame. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Discontinue use if irritation and redness develop. lf condition persists for more than 72 hours consult a physician. 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