Label: LITE NFOAMY E3 HAND SANITIZER- benzalkonium chloride soap
- NDC Code(s): 64009-334-05, 64009-334-08
- Packager: Spartan Chemical Company
- 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.
Updated March 14, 2014
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active Ingredients
Benzalkonium Chloride 0.1%Close
- For hand sanitizing to decrease bacteria on the skin.
- Recommended for repeated use.
- For external use only
Stop use and ask a doctor if irritation and 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.
- Hands must be washed and rinsed with potable water before use.
- Pump a small amount of foam into palm of hand.
- Rub thoroughly over all surfaces of both hands.
- Rub hands together briskly until dry.
- Other Information
- This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
- Do not contaminate water, food or feed by storage and disposal.
- Inactive Ingredients
Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxethyl Cocamine Oxide, Glycereth-17-Cocoate, Citric AcidClose
- Principal Display Panel - Container Label
E3 Hand Sanitizer
Foam Hand Sanitizer- Fragrance Free
- Quickly works to reduce the bacteria on the hands in 15 seconds
- Recommended for use by food service and food processing personnel
FOR INSTITUTIONAL AND INDUSTRIAL USE ONLY
See back panel for additional information.
Spartan Chemical Company, Inc.
1110 Spartan Drive, Maumee, OH 43537 USA
Medical Emergency: 888-314-6171 / www.spartanchemical.com
Net Contents: 1 U.S. Gallon / 3.79 LitersClose
- INGREDIENTS AND APPEARANCE
LITE NFOAMY E3 HAND SANITIZER
benzalkonium chloride soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64009-334 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 1.0 g in 1 L Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetrimonium chloride (UNII: UC9PE95IBP) Laurtrimonium chloride (UNII: A81MSI0FIC) Glycereth-17 cocoate (UNII: 3057VPT0KC) Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5) Citric Acid Monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64009-334-05 3.79 L in 1 CONTAINER 2 NDC:64009-334-08 280.20 L in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2014 Labeler - Spartan Chemical Company (005036728) Establishment Name Address ID/FEI Business Operations Spartan Chemical Company 005036728 MANUFACTURE(64009-334) , LABEL(64009-334)