Label: PROCURE HAND SANITIZING- alcohol swab
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Contains inactivated NDC Code(s)
NDC Code(s): 57544-180-16 - Packager: TwinMed, LLC
- 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 November 18, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- WARNINGS
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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 hole in the container cover. Pull thrugh about one inch. Replace cover. Pull out wipes as needed and sanp off at a 90 degree 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
- Inactive Ingredients
- Labeling
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INGREDIENTS AND APPEARANCE
PROCURE HAND SANITIZING
alcohol swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57544-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65.9 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57544-180-16 320 g in 1 CANISTER; Type 0: Not a Combination Product 05/07/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/07/2013 Labeler - TwinMed, LLC (107071289) Registrant - TwinMed, LLC (107071289) Establishment Name Address ID/FEI Business Operations TwinMed, LLC 107071289 relabel(57544-180) Establishment Name Address ID/FEI Business Operations American Hygienics Corporation 545198454 manufacture(57544-180)