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Product NDC Code | 53118-002 | ||||||||
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Drug Name | Sanitex antibacterial hand wipes fresh scent |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SWAB | ||||||||
RxCUI drug identifier | 1038558 | ||||||||
Application Number | part333A | ||||||||
Labeler Name | Precare Corp | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium Chloride 0.13%
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 adults and children 2 years and over: apply to hands; allow to dry without wiping. children under 2 years: ask a doctor before use. To dispense : Peel back front label slowly. Remove wipes. To reseal : Firmly rub thumb over label. Dispose of wipe in trash. Do not flush. For single wipe sachet Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry without wiping. Dispose of wipe Do not flush
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, 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.Uses For hand sanitizing to decrease bacteria on skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Sanitex Antibacterial Hand Wipes Fresh Scent Benzalkonium Chloride WATER ALCOHOL PHENOXYETHANOL DECYL GLUCOSIDE POTASSIUM SORBATE SODIUM BENZOATE EDETATE DISODIUM CITRIC ACID MONOHYDRATE ALOE VERA LEAF BENZALKONIUM CHLORIDE BENZALKONIUM
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.Principal Display Panel NDC 53118-002-01 Sanitex ® Antibacterial HAND WIPES Kills 99.9% of Germs Enriched with Aloe FRESH SCENT 40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm) NDC 53118-002-02 Sanitex ® Antibacterial HAND WIPES Kills 99.9% of Germs Enriched with Aloe FRESH SCENT 20 wipes| 6 inch x 7 inch (15.2 cm x 17.8 cm) NDC 53118-002-03 Sanitex ® Antibacterial HAND WIPE Kills 99.9% of Germs Enriched with Aloe FRESH SCENT 1 Wipe | 6 inch X 8 inch (15.2 cm X 20.3 cm) Label Label 1 Label 2
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 if you are allergic to any of these ingredients.
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 the reach children. If swallowed, get medical help or contact 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 redness develops, or if condition persists for more than 72 hours.
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 avoid contact with eyes. In case of eye contact, flush eyes with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store below 95 F (35 C) Keep closed tightly. May discolor certain fabrics or surfaces. For single sachet store in a cool dry place
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. Do not use if you are allergic to any of these ingredients. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of the reach children. If swallowed, get medical help or contact Poison Control Center 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