Label: ZYLAST ANTISEPTIC- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 57362-465-04, 57362-465-48 - Packager: Innovative BioDefense
- 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 August 26, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- ASK DOCTOR
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZYLAST ANTISEPTIC
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57362-465 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 44.9 mL in 59.1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57362-465-04 236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/15/2019 2 NDC:57362-465-48 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/24/2015 Labeler - Innovative BioDefense (078363903)