Label: HAND SANITIZER- alcohol gel gel
- NDC Code(s): 83584-016-01
- Packager: PurCel Labs 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 July 24, 2023
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Uses
- Wamings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package label.principal display panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83584-016 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 GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) WATER (UNII: 059QF0KO0R) LEMON OIL (UNII: I9GRO824LL) CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83584-016-01 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/25/2023 Labeler - PurCel Labs LLC (127672531) Registrant - Jiangsu Intco Medical Products Co., Ltd (529128686) Establishment Name Address ID/FEI Business Operations Jiangsu Intco Medical Products Co., Ltd 529128686 manufacture(83584-016)