Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER- alcohol kit
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Contains inactivated NDC Code(s)
NDC Code(s): 50563-207-01, 50563-208-01, 50563-209-01, 50563-210-01 - 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 June 5, 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 UNSCENTED
- Use
- WARNINGS
- Directions
- Other information
- Inactive ingredients
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH CITRUS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- Warnings
- Stop Use
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA
- Active Ingredient
- Purpose
- Uses
- Warnings
- Stop Use
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Fresh Citrus
- BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA
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INGREDIENTS AND APPEARANCE
BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER
alcohol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-210 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-210-01 1 in 1 KIT 06/05/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 60 mL Part 2 1 BOTTLE 60 mL Part 3 1 BOTTLE 60 mL Part 1 of 3 BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED
alcohol solutionProduct Information Item Code (Source) NDC:50563-207 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-207-01 60 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 06/05/2020 Part 2 of 3 BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER FRESH CITRUS
alcohol solutionProduct Information Item Code (Source) NDC:50563-208 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-208-01 60 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 06/05/2020 Part 3 of 3 BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER COCONUT VANILLA
alcohol solutionProduct Information Item Code (Source) NDC:50563-209 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50563-209-01 60 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 06/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/04/2020 Labeler - ENCHANTE ACCESSORIES INC. (186050696) Establishment Name Address ID/FEI Business Operations Xiamen Chengda Industrial Co.,Ltd 540042034 manufacture(50563-210)