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| Product NDC Code | 79067-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanikit |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581662 | ||||
| Application Number | part333A | ||||
| Labeler Name | Renopac, S.A. de C.V. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT - OTC - ACTIVE INGREDIENT SECTION Ethyl Alcohol 70% (w/w)
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 - DOSAGE AND ADMINISTRATION SECTION 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 - INACTIVE INGREDIENT SECTION Purified water, carbomer, glycerin, triethanolamine.
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 - INDICATIONS AND USAGE SECTION Health care personal hand rub to help reduce bacteria that potentially can cause disease
Purpose
Information about the drug product’s indications for use.PURPOSE - OTC - PURPOSE SECTION Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Sanikit Hand Sanitizer Gel ALCOHOL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN TROLAMINE WATER
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 SANIKIT 5g NDC - 79067-004-01 SANIKIT 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 - DO NOT USE SECTION
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 - KEEP OUT OF REACH OF CHILDREN SECTION If swallowed, get medical help por contact a Poison Control 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 A DOCTOR - STOP USE SECTION If irritation or rash occur. These may be signs of a serious condition.
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 - WHEN USING SECTION Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION - STORAGE AND HANDLING SECTION Store between 15-30ºC (59-86ºF) Avoid freezing and excessive heat above 40ºC (104ºF)
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 - WARNINGS SECTIONS For external use only. Flammable. Kepp away from heat or flame.
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