Label: ANTISEPTIC- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61010-7000-0, 61010-7000-1 - Packager: Safetec of America
- 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 June 9, 2011
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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 – packet label
- PRINCIPAL DISPLAY PANEL – box
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-7000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol 715 mL in 1 L Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) alcohol (UNII: 3K9958V90M) acetyltributyl citrate (UNII: 0ZBX0N59RZ) chloroxylenol (UNII: 0F32U78V2Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-7000-1 50 in 1 BOX 1 NDC:61010-7000-0 0.0012 L in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/02/2011 Labeler - Safetec of America (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE