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| Product NDC Code | 77975-010 | ||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Hand sanitizer |
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| Type | Generic | ||||||||||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 1047755 | ||||||||||||||||||||||||||||||||||||||||||
| Application Number | part333A | ||||||||||||||||||||||||||||||||||||||||||
| 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) Alcohol 75%
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 Put enough product In your palm to cover hands and rub handstogether briskly until dry. Children under 6 years of age should be supervised when using thlsproduct to avold swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Delonlzed Water, Aloe Barbadensis Extract, Carbomer, Arginine.
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 that potentially can causedisease. For use when soap and water are not avallableFor external use only. Flammable. Keep away from fire or flame.
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 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER ALCOHOL ALCOHOL ARGININE ALOE VERA LEAF
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 77975-010-11 77975-010-12 77975-010-13 77975-010-14 77975-010-15 77975-010-16 77975-010-17 77975-010-18 77975-010-19 77975-010-20 77975-010-01 77975-010-02 77975-010-03 77975-010-04 77975-010-05 77975-010-06 77975-010-07 77975-010-08 77975-010-09 77975-010-10
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 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 chlldren . If swallowed . get medical help or contacta 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 and lasts.
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 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 Store between 15-30C (59-86F). Avold freezing andexcessive 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 Flammable. Keep away from fire or flame. For external use only.
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