Label: SAFEHANDS- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60867-101-02, 60867-101-07, 60867-101-18 - Packager: safeHands LLC
- 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 September 27, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- Questions/Comments?
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SPL UNCLASSIFIED SECTION
safeHands®
Next Generation Hand Sanitizer
Kills 99.9% of germs while pampering your hands
Learn more at: www.safehands.comA percentage of profits is donated to Safe Kids Worldwide
to “keep all kids safe from preventable injuries”#1 Alcohol Free Brand
Manufactured for safeHands, LLC, Boca Raton, FL
Patent Pending 61/473 385
Made in the USA - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SAFEHANDS
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60867-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRIETHYLENE GLYCOL (UNII: 3P5SU53360) POLYSORBATE 20 (UNII: 7T1F30V5YH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60867-101-02 52 mL in 1 BOTTLE 09/27/2014 2 NDC:60867-101-07 208 mL in 1 BOTTLE 09/27/2014 3 NDC:60867-101-18 532 mL in 1 BOTTLE 09/27/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/27/2014 Labeler - safeHands LLC (061206060) Establishment Name Address ID/FEI Business Operations Products by O2, Inc. 136932444 manufacture(60867-101)