Label: CAREN HAND SANITIZER ANTISEPTIC- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77009-0420-1, 77009-0420-2, 77009-0420-3, 77009-0420-4, view more77009-0420-5 - Packager: Caren Products, 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 September 24, 2020
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- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREN HAND SANITIZER ANTISEPTIC
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77009-0420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.0013 kg in 1 kg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALOE (UNII: V5VD430YW9) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77009-0420-1 0.059 kg in 1 TUBE; Type 0: Not a Combination Product 05/28/2020 2 NDC:77009-0420-2 0.118 kg in 1 TUBE; Type 0: Not a Combination Product 05/28/2020 3 NDC:77009-0420-3 0.948 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/28/2020 4 NDC:77009-0420-4 0.354882 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/24/2020 5 NDC:77009-0420-5 0.709765 kg in 1 POUCH; Type 0: Not a Combination Product 09/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/28/2020 Labeler - Caren Products, LLC (932901676) Establishment Name Address ID/FEI Business Operations Cosco International, Inc. 016433141 manufacture(77009-0420)