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Product NDC Code | 77975-015 | ||||||||||||||||||||||
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Drug Name | Hand sanitizer |
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Type | Generic | ||||||||||||||||||||||
Active Ingredients |
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Route | CUTANEOUS | ||||||||||||||||||||||
Dosage Form | GEL | ||||||||||||||||||||||
RxCUI drug identifier | 581660 | ||||||||||||||||||||||
Application Number | M003 | ||||||||||||||||||||||
Labeler Name | Guangzhou Tingcai Cosmetic Co., Ltd. | ||||||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) ETHYL 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.Directions WET HANS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING FOR children under , use only under adult supervision Not recommedned for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Acrylates/C10-30Alkyl Acrylate Crosspolymer,PEG-40Hydrogenated Castor 0il.
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 Uses To decrease bacteria andgerms on the skin Recommended for repeated use.
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 Hand Sanitizer WATER ALCOHOL ALCOHOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) PEG-40 CASTOR OIL LEMON PEEL
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 77975-012-01 77975-012-02 77975-012-03 77975-012-04 77975-012-05 77975-012-06 77975-012-07 77975-012-08 77975-012-09 77975-012-10
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.
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 chlldren. If swallowed. get medical help or contact a Polson 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 sians 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 throughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not store above 105℉FMay discolor some fabricsHarmful to wood finishesand plastics When using this product: Keepout of eyes. Iin case of contactwith eyes, flush thoroughly withwater. e Do not inhale or ingest.Avoid contact with broken skin.
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