Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER DUO FRESH BERRY SCENTED GRAPEFRUIT SCENTED- alcohol kit
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-394-01, 50563-395-01, 50563-396-01 - Packager: ENCHANTE ACCESSORIES 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 November 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH BERRY SCENTED
- Use
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WARNINGS
For external use only. Flammable.
Keep away from heat or flame
Do not use
- in children less than 2 months of age
- on open skin wounds
When using this product, keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water - Directions
- Other information
- Inactive ingredients
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER GRAPEFRUIT SCENTED
- Active Ingredient
- Purpose
- Uses
- Warnings
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER DUO FRESH BERRY SCENTED GRAPEFRUIT SCENTED
alcohol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-396 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-396-01 1 in 1 KIT 10/30/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 mL Part 2 1 BOTTLE 30 mL Part 1 of 2 BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH BERRY SCENTED
alcohol solutionProduct Information Item Code (Source) NDC:50563-394 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-394-01 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/30/2020 Part 2 of 2 BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER GRAPEFRUIT SCENTED
alcohol solutionProduct Information Item Code (Source) NDC:50563-395 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-395-01 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/30/2020 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Establishment Name Address ID/FEI Business Operations Xiamen Afgamarine Biotechnology Co., Ltd. 420485152 manufacture(50563-396)