Label: ALPHA FOAMING E-2- benzalkonium chloride soap
- NDC Code(s): 65585-510-01, 65585-510-02
- Packager: Whisk Products, Inc.
- 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.
Updated July 14, 2017
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- Active Ingredient
Benzalkonium Chloride 0.13%Close
- For hand washing to decrease bacteria on the skin
- Recommended for repeated use
For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Pump a small amount of foam into palm of hand.
- Rub thoroughly over all surfaces of both hands for 15 seconds.
- Rinse with potable water.
- Inactive Ingredients
Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid, fragranceClose
- INGREDIENTS AND APPEARANCE
ALPHA FOAMING E-2
benzalkonium chloride soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-510 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO GLUCOSIDE (UNII: ICS790225B) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color white (water-white, dispensed as a white foam) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65585-510-01 4 in 1 BOX 10/22/2012 1 1000 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:65585-510-02 8 in 1 BOX 10/22/2012 2 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/22/2012 Labeler - Whisk Products, Inc. (834270639) Establishment Name Address ID/FEI Business Operations Whisk Products, Inc. 834270639 manufacture(65585-510)