Label: ISSENGARD 24 HAND SANITIZER 3 OZ- benzalkonium chloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81495-112-03 - Packager: Clear Lake Research, 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 December 30, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE SECTION
- WARNINGS
- USES
- WHEN USING SECTION
- STOP USE AND ASK A DOCTOR
- KEEP OUT OF REACH OF CHILDREN SECTION
- DIRECTIONS
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INACTIVE INGREDIENTS
Water (Aqua), Glycine soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Tributyl Phosphate, Glycerin, t-Octylphenoxy-polyethoxyethanol, Hydroxy- ethylacrylate/Sodium Acryloyldimethyl Taurate, Copolymer, Isohexadecane, Polysorbate 60, Glyceryl Stearate, Stearic Acid, Stearyl Alcohol, Lavandula angustifolia (Lavender) Oil, Propylene Glycol, Ethyl Alcohol, Zinc Oxide CI 77947
- PRINCIPAL DISPLAY PANEL - 89 mL
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INGREDIENTS AND APPEARANCE
ISSENGARD 24 HAND SANITIZER 3 OZ
benzalkonium chloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81495-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.18 mg in 100 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) LAVENDER OIL (UNII: ZBP1YXW0H8) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5) STEARIC ACID (UNII: 4ELV7Z65AP) ZINC OXIDE (UNII: SOI2LOH54Z) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) POLYSORBATE 60 (UNII: CAL22UVI4M) SOYBEAN OIL (UNII: 241ATL177A) OCTOXYNOL-1 (UNII: 20CAX7IO75) ISOHEXADECANE (UNII: 918X1OUF1E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81495-112-03 89 mL in 1 TUBE; Type 0: Not a Combination Product 03/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/22/2021 Labeler - Clear Lake Research, LLC (077493647) Establishment Name Address ID/FEI Business Operations Columbia Cosmetic Manufacturing, Inc 068267863 manufacture(81495-112) Establishment Name Address ID/FEI Business Operations Clear Lake Research, LLC 077493647 label(81495-112)
