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Product NDC Code | 80652-002 | ||||
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Drug Name | Scented hand sanitizer - vanilla scented |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 581660 | ||||
Application Number | part333A | ||||
Labeler Name | Little Kids, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Denatured Ethyl alcohol 62% 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 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 Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Triethanolamine, Water, D&C Red NO.33, FD&C Yellow No.5, FD&C Blue No.1.
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 To decrease bacteria on the skin that could cause disease . For use when soap and water are not available.
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.Scented Hand Sanitizer - Citrus Scented ALCOHOL FD&C YELLOW NO. 5 CARBOMER INTERPOLYMER TYPE A (55000 CPS) GLYCERIN PROPYLENE GLYCOL WATER ALCOHOL ALCOHOL TROLAMINE ALOE VERA LEAF MALTODEXTRIN Scented Hand Sanitizer - Strawberry Scented ALCOHOL CARBOMER INTERPOLYMER TYPE A (55000 CPS) GLYCERIN PROPYLENE GLYCOL WATER ALCOHOL ALCOHOL ALOE VERA LEAF MALTODEXTRIN TROLAMINE D&C RED NO. 33 FD&C RED NO. 4 Scented Hand Sanitizer - Vanilla Scented ALCOHOL CARBOMER INTERPOLYMER TYPE A (55000 CPS) GLYCERIN PROPYLENE GLYCOL WATER ALCOHOL ALCOHOL ALOE VERA LEAF MALTODEXTRIN TROLAMINE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 D&C RED NO. 33 Scented Hand Sanitizer - Cherry Blossom Scented ALCOHOL FD&C YELLOW NO. 5 D&C RED NO. 33 WATER CARBOMER INTERPOLYMER TYPE A (55000 CPS) GLYCERIN PROPYLENE GLYCOL ALCOHOL ALCOHOL ALOE VERA LEAF MALTODEXTRIN TROLAMINE FD&C BLUE NO. 1 ALUMINUM LAKE
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 - Citrus Scented Citrus Scented PDP
Package Label - Principal Display Panel - Strawberry Scented Strawberry Scent
Package Label - Principal Display Panel - Vanilla Scented Vanilla Scent
Package Label - Principal Display Panel - Cherry Blossom Scented Cherry Blossom Scent
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. 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. 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: 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. In case of contact with eyes, flush eyes thoroughly with water. on open skin wounds. on children less than 2 months of age.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not store above 105 o F
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 fire 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