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| Product NDC Code | 78994-070 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizer gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581662 | ||||
| Application Number | part333E | ||||
| Labeler Name | RFH BioTek Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Alcohol 70% v/v
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 Put enough product in palm to cover hands. Rub briskly until dry. Supervise children under 6 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER, GLYCERIN, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, SILVER.
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 This rinse-free hand gel moisturizes the hands while cleaning and helps to reduce bacteria that potentially can cause disease.
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.Hand Sanitizer gel Alcohol WATER GLYCERIN CAPRYLYL GLYCOL AMINOMETHYLPROPANOL SILVER ALCOHOL ALCOHOL ETHYLHEXYLGLYCERIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
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.HAND SANITIZER GEL WITH pure SILVER Cleans & care for hands Provides moisture & refreshes Dries fast and is not sticky Improves hand hygiene by reducing bacteriria MicroSilver BG™ 99.99% ANTIBACTERIAL 1. 50 ML
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 On children less than 2 months of age. Avoid contact with broken skin.
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 and contact a Poison Control Centre 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 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 PRODUCTS 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 Store in a cool, dry place, keep away from direct sunlight. Store between 15-30C (59-86F). Avoid Freezing and excess 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. Flammable. Keep 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