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| Product NDC Code | 60637-219 | ||||
|---|---|---|---|---|---|
| Drug Name | Justice berry scented anti-bacterial hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 581660 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Tween Brands, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Alcohol 62%
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.Use For hand washing to decrease bacteria on the skin Recommended for repeated use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, polyethylene terephthalate, acrylates copolymer, FD&C red No. 40, D&C Red No. 33
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.Directions Wet hands thoroughly with product and allow to dry without wiping
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.Justice Berry Scented Anti-bacterial Hand Sanitizer Alcohol WATER GLYCERIN PROPYLENE GLYCOL CARBOXYPOLYMETHYLENE 2,4-D-TROLAMINE POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) FD&C RED NO. 40 D&C RED NO. 33 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.package label 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 gel medical helpo r contact a Poison Control Center right away Supervise children in the use of this product
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 Flammable, keep away from fire or flame For external use only. Do not use in the eyes the eyes or apply the eyes or apply over large areas of the body In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor Use only directed. Do not drink. If taken internally, it will produce serious gastric disturbance Stop use and ask a doctor if irritation persists for more than 72 hours Keep out of reach of children If swallowed gel medical helpo r contact a Poison Control Center right away Supervise children in the use of this product
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