Label: MY-SHIELD TOPICAL ANTISEPTIC- benzalkonium chloride gel
- NDC Code(s): 71884-025-01, 71884-025-04, 71884-025-06, 71884-025-08
- 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 24, 2022
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INGREDIENTS AND APPEARANCE
MY-SHIELD TOPICAL ANTISEPTIC
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71884-025 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:71884-025-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2022 2 NDC:71884-025-06 59 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2022 3 NDC:71884-025-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2022 4 NDC:71884-025-08 177 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/24/2022 Labeler - Enviro Specialty Chemicals Inc (202621850)