Label: LEMON SANITIZING COLOGNE- alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 80848-003-01 - Packager: L3VEL3 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 October 16, 2020
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- Official Label (Printer Friendly)
- Purpose
- Description
- Directions:
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Active Ingredient(s)
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
LEMON SANITIZING COLOGNE
alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80848-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.016 mL in 100 mL HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) 0.032 mL in 100 mL ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) 0.025 mL in 100 mL COUMARIN (UNII: A4VZ22K1WT) 0.045 mL in 100 mL LIMONENE, (+/-)- (UNII: 9MC3I34447) 0.039 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80848-003-01 250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/15/2020 Labeler - L3VEL3 LLC (128877852) Establishment Name Address ID/FEI Business Operations KOZMOTEK PAZARLAMA KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI 505246218 manufacture(80848-003)
250 mL NDC: 80848-003-01