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| Product NDC Code | 82092-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 902515 | ||||
| Application Number | part333A | ||||
| Labeler Name | Rebel Rebel Personal Care Corp. | ||||
| 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(s) Ethyl Alcohol 65%. Purpose: 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 Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Non Active Ingredients: Purified Water, Aloe Barbadensis Extract, Glycerin, Polysorbate 20, Denatonium Benzoate, 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 Antiseptic (skin) cleanser to help reduce bacteria on skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer ALCOHOL POLYSORBATE 20 DENATONIUM BENZOATE ALOE VERA LEAF GLYCERIN WATER ALCOHOL ALCOHOL Hand Sanitizer ALCOHOL PHENYLETHYL ALCOHOL 2-ACETONAPHTHONE ETHYL METHYLPHENYLGLYCIDATE DENATONIUM BENZOATE ALOE VERA LEAF GLYCERIN WATER ALCOHOL ALCOHOL HEXAMETHYLINDANOPYRAN POLYSORBATE 20 METHYL ANTHRANILATE GERANIOL .ALPHA.-HEXYLCINNAMALDEHYDE 2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE Hand Sanitizer ALCOHOL DENATONIUM BENZOATE LINALOOL, (+/-)- PHENYLETHYL ALCOHOL PIPERONAL LINALYL ACETATE GERANYL ACETATE .ALPHA.-AMYLCINNAMALDEHYDE PENTADECALACTONE BENZYL SALICYLATE ALOE VERA LEAF POLYSORBATE 20 GLYCERIN WATER 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 - Principal Display Panel 60 mL NDC: 82092-001-01 60 mL NDC: 82092-002-01 60 mL NDC: 82092-003-01 60 ml French Lavender NDC 82092 001 01 60 ml French Lavender NDC 82092 001 01 60 ml Magnolia NDC 82092 002 01 60 ml Magnolia NDC 82092 002 01 60 ml Hawaiian Plumeria NDC 82092 003 01 60 ml Hawaiian Plumeria NDC 82092 003 01
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.Changes to: Recommended Use: Antiseptic (skin) cleanser to help reduce bacteria on skin. Direction: Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F). Warnings: Keep out of reach of children. For external use only. Flammable. Keep away from flame and heat. When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed get medical help or contact poison control centre right away.
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
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 in children less than 2 months of age on open skin wounds
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.
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 occurs. 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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. 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 (59-86F) 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 Keep out of reach of children. For external use only. Flammable. Keep away from flame and heat. When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed get medical help or contact poison control centre right away.
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