Label: PROCLEAN HAND SANITIZER- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77110-220-01, 77110-220-02, 77110-220-03 - Packager: Biominerales Pharma
- 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 September 9, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Inactive ingredients
- Use(s)
- Warnings
- Directions
- PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label
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INGREDIENTS AND APPEARANCE
PROCLEAN HAND SANITIZER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77110-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROGEN PEROXIDE (UNII: BBX060AN9V) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77110-220-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2020 2 NDC:77110-220-02 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2020 3 NDC:77110-220-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 09/15/2020 Labeler - Biominerales Pharma (117489663) Establishment Name Address ID/FEI Business Operations Biominerales Pharma 117489663 MANUFACTURE(77110-220)