Label: ALPHA E-2- benzalkonium chloride soap
- NDC Code(s): 65585-495-01
- Packager: Whisk Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient
Benzalkonium Chloride 2.5%Close
reduces amount of bacteria on handsClose
Avoid contact with eyes. If contents come in contact with eyes, flush with water for at least 15 minutes and get medical attention.
For external use only.
If irritation develops, use of this product should be discontinued. If irritation persists for more than 72 hours, consult a physician.
Do not allow concentrate to come in contact with food.
For institutional and professional use only.Close
- Hands need not be washed prior to using.
- Dispense a small amount into palm of hand.
- Wash for at least 15 seconds.
- Rinse with potable water.
- Repeat as needed.
- Inactive Ingredients
Water, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, PEG-6 Cocamide, Hydroxypropyl Methylcellulose, Quaternium-15, Citric Acid, Sodium HydroxideClose
- INGREDIENTS AND APPEARANCE
benzalkonium chloride soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-495 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) PEG-6 COCAMIDE (UNII: YZ6NLA4O1E) HYPROMELLOSES (UNII: 3NXW29V3WO) QUATERNIUM-15 (UNII: E40U03LEM0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color yellow (very pale yellow - very pale gold) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65585-495-01 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/21/2008 Labeler - Whisk Products, Inc. (834270639) Establishment Name Address ID/FEI Business Operations Whisk Products, Inc. 834270639 manufacture(65585-495)