Label: FIRST AID ANTISEPTIC WIPES (benzalkonium chloride- 0.13% cloth
- NDC Code(s): 0363-0589-01
- Packager: Walgreen CO
- 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 March 22, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- Do Not Use
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions:
- Inactive ingredients
- adverse reactions
- principal display panel
-
INGREDIENTS AND APPEARANCE
FIRST AID ANTISEPTIC WIPES
benzalkonium chloride (0.13%) clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0589 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE .0013 mg in 100 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 20 (UNII: 7T1F30V5YH) EDETATE SODIUM (UNII: MP1J8420LU) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0589-01 20 in 1 CARTON 02/08/2017 1 1 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/08/2017 Labeler - Walgreen CO (008965063) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Albaad 143406457 manufacture(0363-0589)