Label: HAND SANITIZER - ITALIAN LEMON AND LIME- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80038-003-01, 80038-003-02, 80038-003-03 - Packager: Phenom Marketing Group, Inc.
- 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 February 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER - ITALIAN LEMON AND LIME
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80038-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 85 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.72 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80038-003-01 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/06/2020 2 NDC:80038-003-02 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/06/2020 3 NDC:80038-003-03 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/06/2020 Labeler - Phenom Marketing Group, Inc. (046354714) Establishment Name Address ID/FEI Business Operations Phenom Marketing Group, Inc. 046354714 manufacture(80038-003)
