Label: PROANDRE- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 70028-002-01 - Packager: PROANDRE, SL
- 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 November 25, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Purpose
- Uses
- WARNINGS
- Stop use and ask doctor if
- Keep Out of reach of children
- Questions?.
- Dossage and Administration
- Inactive ingredients
- ANTIBACTERIAL ANTIBACT SOAP LIQUID
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INGREDIENTS AND APPEARANCE
PROANDRE
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70028-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 80.079 mg in 1 mL COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 18.1 mg in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.9 mg in 1 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.3 mg in 1 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.3 mg in 1 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.02 mg in 1 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.0005 mg in 1 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0005 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70028-002-01 800 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/26/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/20/2015 Labeler - PROANDRE, SL (463207675) Registrant - PROANDRE, SL (463207675) Establishment Name Address ID/FEI Business Operations PROANDRE, SL 463207675 manufacture(70028-002)
