Label: PPEBUDDY- alcohol kit
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Contains inactivated NDC Code(s)
NDC Code(s): 79437-000-00, 79437-003-00, 79437-004-00 - Packager: PPE Buddy 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 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Use
- Warnings
- Directions:
- Other Information:
- Inactive Ingredients:
- Drug facts
- Active Ingredients
- Use
- Warnings
- Directions:
- Inactive Ingredients:
- Kit Labeling:
- Package Labeling:79437-000-00
- Package Labeling:79437-003-00
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INGREDIENTS AND APPEARANCE
PPEBUDDY
alcohol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79437-004 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79437-004-00 1 in 1 KIT 07/24/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 2 mL Part 2 1 PATCH 4 mL Part 1 of 2 PPEBUDDY SINGLE USE HAND SANITIZER S001
alcohol gelProduct Information Item Code (Source) NDC:79437-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79437-000-00 2 mL in 1 PACKET; 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 part333E 07/24/2020 Part 2 of 2 PPEBUDDY DISINFECTING WIPE D001
alcohol clothProduct Information Item Code (Source) NDC:79437-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79437-003-00 1 in 1 PACKET 1 4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/24/2020 Labeler - PPE Buddy LLC (117556781)
