Label: CLEAN N NATURAL HAND SANITIZER ANTIMICROBIAL- alcohol gel
- NDC Code(s): 67385-026-01, 67385-026-02
- Packager: Garcoa, 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 January 27, 2022
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- PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
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INGREDIENTS AND APPEARANCE
CLEAN N NATURAL HAND SANITIZER ANTIMICROBIAL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67385-026 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 700 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) Glycerin (UNII: PDC6A3C0OX) Isopropyl Myristate (UNII: 0RE8K4LNJS) Propylene Glycol (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67385-026-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/04/2020 2 NDC:67385-026-02 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 06/04/2020 Labeler - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan America, LLC 964976968 MANUFACTURE(67385-026)