Label: ANTIBACTERIAL HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73563-080-01, 73563-080-02, 73563-080-04, 73563-080-06, view more73563-080-07, 73563-080-08, 73563-080-12, 73563-080-18, 73563-080-32 - Packager: Body One Products , 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 August 7, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 1064 ML Bottle Label
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73563-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73563-080-02 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2020 2 NDC:73563-080-18 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2020 3 NDC:73563-080-32 1064 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2020 07/31/2020 4 NDC:73563-080-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2020 5 NDC:73563-080-04 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2020 6 NDC:73563-080-01 29.5 mL in 1 TUBE; Type 0: Not a Combination Product 08/05/2020 7 NDC:73563-080-06 66 mL in 1 TUBE; Type 0: Not a Combination Product 07/20/2020 8 NDC:73563-080-07 7 mL in 1 PACKET; Type 0: Not a Combination Product 05/15/2020 9 NDC:73563-080-12 355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 03/10/2020 Labeler - Body One Products , Inc. (117376115) Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc. (078831987) Establishment Name Address ID/FEI Business Operations BMC 1092, Inc. dba Solo Laboratories, Inc. 078831987 MANUFACTURE(73563-080) , LABEL(73563-080) , PACK(73563-080)