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| Product NDC Code | 57337-018 | ||||
|---|---|---|---|---|---|
| Drug Name | Instant hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M003 | ||||
| Labeler Name | Rejoice International, Inc. | ||||
| 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 Purpose Ethyl Alcohol 62.0%......................Antimicrobial
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: wet hands thoroughly with product briskly rub hands together until dry children under 6 years of age should be supervised by an adult when using.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.
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: hand sanitizer to help reduce bacteria on the skin that may cause disease
Purpose
Information about the drug product’s indications for use.XtraCare Instant Hand Sanitizer - Original Kills 99.9% of Germs with Moisturizers & Vitamin E
Spl product data elements
Usually a list of ingredients in a drug product.Instant Hand Sanitizer Ethyl Alcohol WATER GLYCERIN ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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.bottle label package label
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.Warnings: for external use only. Flammable. Keep away from heat and flame. Do not use in the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
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