Label: PDI SANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL HAND WIPES- alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 10819-5001-2 - Packager: Profesional Disposables International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 21, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Uses
- Warnings
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Directions
- Tear open packet.
- Open and unfold towelettes
- Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface.
- For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe. Allow to dry.
- If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe.
- Discard after single use.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - 1000 Packets per Box - Bulk
- Active ingredient
- Purpose
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INGREDIENTS AND APPEARANCE
PDI SANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL HAND WIPES
alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-5001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 0.659 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10819-5001-2 1000 in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2008 Labeler - Profesional Disposables International, Inc. (800777117) Establishment Name Address ID/FEI Business Operations Profesional Disposables International, Inc. 800777117 manufacture