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Crazy cleanz foaming hand sanitizer - eucalyptus - Medication Information

Product NDC Code 77006-010
Drug Name

Crazy cleanz foaming hand sanitizer - eucalyptus

Type Brand
Active Ingredients
Benzalkonium chloride 200 mg/100ml
Route TOPICAL
Dosage Form LIQUID
Application Number part333E
Labeler Name WeCool Toys, Inc.
Packages
Package NDC Code Description
77006-010-01 50 ml in 1 bottle, pump (77006-010-01)
77006-010-02 250 ml in 1 bottle, pump (77006-010-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT(S) Purpose Benzalkonium Chloride 0.10%..................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 * Place enough product on hands to cover all surfaces. * Rub hands together until dry. * 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: Deionized water Glycerin Didecyldimonium chloride FD&C Blue 1 FD&C Yellow 5 Fragrance - Eucalyptus Limonene Linalool PEG-40 hydrogenated castor oil Polyaminopropyl biguanide

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.
DO NOT USE * in children less than 2 months of age * On open skin wounds WHEN USING THIS PRODUCT keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thouroughly with water. STOP USE AND ASK A DOCTOR if irritation or rash occures. These may be a sign of a serious condition.

Purpose

Information about the drug product’s indications for use.
Use(s): Helps eliminate bacteria on hands.

Spl product data elements

Usually a list of ingredients in a drug product.
Crazy Cleanz Foaming Hand Sanitizer - Eucalyptus Benzalkonium Chloride FD&C YELLOW NO. 5 GLYCERIN DIDECYLDIMONIUM CHLORIDE POLIHEXANIDE HYDROCHLORIDE LIMONENE, (+)- BENZALKONIUM CHLORIDE BENZALKONIUM POLYOXYL 50 HYDROGENATED CASTOR OIL DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM WATER LINALOOL, (+/-)-

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.
NDC 77006-010 RNLabel

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
Changed title of sections.

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, except under adult supervision. 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 between 15-30C (56-86F) *Avoid freezing and excessive heat above 40C (104F)

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