Label: GUNK GETTER SANITIZING- benzalkonium chloride spray
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NDC Code(s):
83590-002-01,
83590-002-02,
83590-002-03,
83590-002-04, view more83590-002-05
- Packager: PeerBasics 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 August 24, 2023
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- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUNK GETTER SANITIZING
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83590-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) (LAURAMIDOPROPYLAMINE OXIDE - UNII:I6KX160QTV) LAURAMIDOPROPYLAMINE OXIDE 1.5 mg in 100 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83590-002-01 80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/20/2023 2 NDC:83590-002-02 98 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/20/2023 3 NDC:83590-002-03 473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/20/2023 4 NDC:83590-002-04 828 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/20/2023 5 NDC:83590-002-05 946 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/20/2023 Labeler - PeerBasics LLC (087291627) Establishment Name Address ID/FEI Business Operations Hangzhou Huiji Biotechnology Co.,Ltd 526893497 manufacture(83590-002)