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| Product NDC Code | 81351-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Saninta antiseptic wipe |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | LL Pharma | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Isopropyl alcohol 70% 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 Wipe hands thoroughly and carefully for at least 30 seconds. Allow to 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 Purified Water USP
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 wipe to help reduce bacteria that potentially can 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.Saninta Antiseptic Wipe ALCOHOL WATER ISOPROPYL ALCOHOL ISOPROPYL 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 NDC: 81351-001-01 Product: 001-01 Effective for hand sanitizing For personal hand hygiene to help prevent the spread of bacteria Saninta Antiseptic Wipe Antiseptic Alcohol Wipe Isopropyl Alcohol 70% USP 51 Unit large wipes 8" x 4 3/4 " wipes Manufactured by: LL Pharma Inc. 5789 rue Cypihot, Saint-Laurent (Montreal), Quebec H4S 1R3 Made in Canada www.llpharmainc.com LOT #: EXP.: F001 VER. 01 RE: 01-2021 image of 81351-001-01 individual packet image of 81351-001-01 outer box of 51
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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Questions or Comments? Tel.: 1-833-336-6159
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 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 When using this product Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store between 15ºC - 30ºC (59º-86ºF) Avoid freezing and excessive heat above 40ºC (104ºF).
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. Do not use Do not use In children less than 2 months of age On open skin wounds When using this 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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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