Label: CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52138-100-50 - Packager: Cleanphirst, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 1, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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PRINCIPAL DISPLAY PANEL
CLEANpHIRST
Alcohol Free
Antiseptic Hand Sanitizer
Kills up to 99.999 percent of germs
leaves skin soft
Won't Dry Out Hands
www.cleanphirst.com
125 Applications/1.7fl oz (50mL)
Manufactured by: MicroPure Solutions, LLC
1055 Stevenson Ct., Suite 15 W
Roselle, IL 60172
United States
Exp. Date:
Lot No.: - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52138-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mL in 100 mL Inactive Ingredients Ingredient Name Strength BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CARBONATE (UNII: BQN1B9B9HA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52138-100-50 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 05/12/2010 Labeler - Cleanphirst, LLC (833241438) Establishment Name Address ID/FEI Business Operations MicroPure Solutions, LLC 805764508 manufacture