Label: HAND SANITIZER- alcohol gel
- NDC Code(s): 71569-370-88
- Packager: Jubilant, 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 March 3, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds
DISTRIBUTED BY: Jubilant LLC
451 Broadway, F12
New York, NY 10013
www.princeSpring.com
Pat. 9,161,982
SDS-MO-15036
SDA-WI-2486
DSP-MO-28
DSP-MO-34
Questions? Comments? 732-783-4090
hi@princespring.com
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71569-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) SULISOBENZONE (UNII: 1W6L629B4K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71569-370-88 2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/11/2017 Labeler - Jubilant, LLC (079508724) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(71569-370) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(71569-370)