Label: HAND SANITIZER ALCOHOL BASED FORMULA- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75115-128-01 - Packager: Soapbox Soaps, 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 31, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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- Other Information
- Inactive Ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label
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INGREDIENTS AND APPEARANCE
HAND SANITIZER ALCOHOL BASED FORMULA
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75115-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) PEG-7 Glyceryl Cocoate (UNII: VNX7251543) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Aloe vera leaf (UNII: ZY81Z83H0X) AminoMethylPropanol (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75115-128-01 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 08/03/2020 Labeler - Soapbox Soaps, LLC (034861706) 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(75115-128) , LABEL(75115-128) , PACK(75115-128)