Label: GERM FREE TOPICAL ANTISEPTIC- benzalkonium chloride gel
- NDC Code(s): 71884-008-02
- Packager: Enviro Specialty Chemicals 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.
Drug Label Information
Updated February 23, 2022
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SPL UNCLASSIFIED SECTION
Formulated with Zetrisil®
One spray lasts all day
Long lasting, alcohol-free protection from germs.
FOR MINOR CUTS, SCRAPES & BURNS
KILLS 99.99% OF HARMFUL GERMS
MAXIMUM STRENGTH
MOISTURIZES WITH ALOE VERA
MADE IN THE USA
Distributed by: ESC Brands, LLC.
664 Old Hargraves Road - Suite B
Lexington, NC 27295
www.germ-free24.com
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INGREDIENTS AND APPEARANCE
GERM FREE TOPICAL ANTISEPTIC
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71884-008 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) LAURETH-4 (UNII: 6HQ855798J) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) POLIHEXANIDE (UNII: 322U039GMF) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71884-008-02 57 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/01/2018 Labeler - Enviro Specialty Chemicals Inc (202621850)