Label: PDI SANI-HANDS INSTANT HAND SANITIZING WIPES- alcohol cloth
- NDC Code(s): 10819-3917-1, 10819-3917-2
- Packager: Professional 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 October 20, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Uses
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Warnings
- For external use only
- Flammable. Keep away from fire or flame.
- When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- Do not use in or contact with eyes.
- Stop use and ask a doctor if irritation or redness develops and continues for more than 72 hours
- Discontinue use if irritation and redness develop. If condition for more persists for more than 72 hours, consult a doctor
- Inactive ingredients
- Active ingredient
- Purpose
- Keep out of reach of children
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Directions
- To start feed: Remove cover and discard seal from container. From center of toweled roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at a 90 o angle. Keep cap closed to prevent evaporation.
- Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. 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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PDI SANI-HANDS INSTANT HAND SANITIZING WIPES
alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10819-3917 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.659 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10819-3917-2 814 mL in 1 CANISTER; Type 0: Not a Combination Product 03/24/2014 2 NDC:10819-3917-1 500 mL in 1 CANISTER; Type 0: Not a Combination Product 03/24/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/24/2014 Labeler - Professional Disposables International, Inc. (800777117) Establishment Name Address ID/FEI Business Operations Professional Disposables International, Inc. 800777117 manufacture(10819-3917)
