Label: INSTANT HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 55305-111-10, 55305-111-11, 55305-111-12 - Packager: Aero Healthcare
- 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 30, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL – 2 fl. oz. Bottle Label
- PRINCIPAL DISPLAY PANEL – 4 fl. oz. Bottle Label
- PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label
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INGREDIENTS AND APPEARANCE
INSTANT HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55305-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 0.665 g in 1 mL Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) carbomer interpolymer type a (55000 mpa.s) (UNII: 59TL3WG5CO) d&c green no. 5 (UNII: 8J6RDU8L9X) d&c yellow no. 10 (UNII: 35SW5USQ3G) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55305-111-10 60 mL in 1 BOTTLE, PLASTIC 2 NDC:55305-111-11 120 mL in 1 BOTTLE, PLASTIC 3 NDC:55305-111-12 240 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/30/2013 Labeler - Aero Healthcare (008186174) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(55305-111)
