Label: PURIDERM ANTIBACTERIAL- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51774-002-08, 51774-002-12, 51774-002-16, 51774-002-28, view more51774-003-08, 51774-003-12, 51774-003-16, 51774-003-28, 51774-004-08, 51774-004-12, 51774-004-16, 51774-004-28 - Packager: INDUSTRIAS CHAMER S.A. DE C.V.
- 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 August 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
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Inactive Ingredients
Aqua (Water), Sodium Laureth Sulfate, Sodium chloride, Cocamidopropyl Betaine, Cocamidopropyl PG Dimonium Chloride, Lauryl Glucoside, Glycerin, Parfum (Fragance), Aloe Barbadensis Extract, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone (and) Methylisothiazolinone, CI 42090, CI 19140, CI 17200.
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- PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - Spring Fresh
- PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - Lavender Vanilla
- PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - Fruit Explosion
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INGREDIENTS AND APPEARANCE
PURIDERM ANTIBACTERIAL
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51774-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) 7.5 mg in 1 mL WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color TURQUOISE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51774-002-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 2 NDC:51774-002-12 360 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 3 NDC:51774-002-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 4 NDC:51774-002-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/24/2020 PURIDERM ANTIBACTERIAL
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51774-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) 7.5 mg in 1 mL WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color PURPLE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51774-003-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 2 NDC:51774-003-12 360 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 3 NDC:51774-003-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 4 NDC:51774-003-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/24/2020 PURIDERM ANTIBACTERIAL
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51774-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) 7.5 mg in 1 mL WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51774-004-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 2 NDC:51774-004-12 360 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 3 NDC:51774-004-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 4 NDC:51774-004-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/24/2020 Labeler - INDUSTRIAS CHAMER S.A. DE C.V. (850602483) Establishment Name Address ID/FEI Business Operations INDUSTRIAS CHAMER S.A. DE C.V. 850602483 MANUFACTURE(51774-002, 51774-003, 51774-004)
