Label: SAFE CLEAN PROTECTION KIT- ethyl alcohol 75% kit
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Contains inactivated NDC Code(s)
NDC Code(s): 79312-101-01, 79312-102-01, 79312-103-04 - Packager: Mimish Designs, 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 July 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Safe+Clean Protective Kit
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INGREDIENTS AND APPEARANCE
SAFE CLEAN PROTECTION KIT
ethyl alcohol 75% kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79312-103 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79312-103-04 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 05/01/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 POUCH 1 mL Part 2 1 POUCH 1 Part 1 of 2 SAFE CLEAN HAND SANITIZER
ethyl alcohol 75% gelProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 1.125 mL in 1.5 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) WATER (UNII: 059QF0KO0R) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) GLYCERIN (UNII: PDC6A3C0OX) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79312-101-01 1.5 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2020 Part 2 of 2 SAFE CLEAN ALCOHOL WET WIPE
ethyl alcohol 75% swabProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79312-102-01 1 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2020 Labeler - Mimish Designs, LLC (131433402) Registrant - Mimish Designs, LLC (131433402)
