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| Product NDC Code | 42681-0041 | ||||
|---|---|---|---|---|---|
| Drug Name | 365 spiced balsam hand sanitizer wipes |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 884787 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Whole Foods Market, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alcohol 65% 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 ■ remove and unfold wipe ■ wet hands thoroughly with product and let air dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Glycerin, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Polysorbate 20, 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 the skin when water and soap are not available. ■ 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.365 Spiced Balsam Hand Sanitizer Wipes Alcohol Hand Sanitizer OAT ALOE VERA LEAF ALCOHOL ALCOHOL ALTHAEA OFFICINALIS ROOT GLYCERIN GREEN TEA LEAF CHAMOMILE CUCUMBER POLYSORBATE 20 WATER
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 42681-0041-1 365 WHOLE FOODS MARKET REFRESHING WIPES Hand Sanitizer Spiced Balsam 99.9% effective against most common germs* Made without benzalkonium chloride Limited EDITION PEEL & SEAL 10 WIPES 6IN x 7.5IN (15.24cm x 19.05cm) DO NOT FLUSH Drug Facts Active Ingredient Purpose Ethyl Alcohol 65% v/v....................Antimicrobial Warnings For external use only. Flammable: keep away from fire or flame. When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water. Stop use and contact a doctor if irritation or redness persists for more than 72 hours. Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away. Directions ■ remove and unfold wipe ■ wet hands thoroughly with product and let air dry Inactive ingredients Water, Glycerin, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Polysorbate 20, Fragrance. Questions, Comments? ■ 1-844-WFM-TALK (1-844-936-8255) DISTRIBUTED BY: WHOLE FOODS MARKET AUSTIN, TX 78703 ©2024 WHOLE FOODS MARKET IP, LP www.wholefoodsmarket.com WARNING: THESE WIPES CONTAIN ALCOHOL, WHICH CAN DISCOLOR SOME FABRICS AND SURFACES. ALWAYS TEST AN INCONSPICUOUS SPOT FIRST. DISCLAIMER: ALCOHOL EVAPORATES WITH TIME. TO KEEP THESE WIPES FRESH AND EFFECTIVE, RESEAL SECURELY AFTER EACH USE AND STORE AT 75°F OR BELOW. KEEP OUT OF DIRECT SUNLIGHT. DISCARD AFTER USE. DO NOT FLUSH. *ESCHERICHIA COLI, STAPHYLOCOCCUS AUREUS, SALMONELLA TYPHIMURIUM, PSEUDOMONAS AERUGINOSA, BURKHOLDERIA CEPACIA, ENTEROBACTER CLOACAE, ENTEROCOCCUS FAECALIS, STREPTOCOCCUS PYOGENES, CANDIDA ALBICANS, ASPERGILLUS BRASILIENSIS. Made Without: Benzalkonium Chloride, Parabens or Triclosan Glycerin & Aloe Vera to replace moisture 99.9% effective against most common germs* FSC MIX Paper FSC C109834 0 99482 53205 5 LABEL LABEL
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 unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions, Comments? ■ 1-844-WFM-TALK (1-844-936-8255)
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. When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water. Stop use and contact a doctor if irritation or redness persists for more than 72 hours.
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