Label: PRIME- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 79382-002-01, 79382-002-02, 79382-002-03, 79382-002-04, view more79382-002-05, 79382-002-06, 79382-002-07 - Packager: Prime Industries Usa, 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 August 4, 2020
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
PRIME
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79382-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) GLYCERIN (UNII: PDC6A3C0OX) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79382-002-01 332 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/2020 2 NDC:79382-002-02 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/2020 3 NDC:79382-002-03 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/2020 4 NDC:79382-002-04 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/2020 5 NDC:79382-002-05 5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/04/2020 6 NDC:79382-002-06 100000 mL in 1 DRUM; Type 0: Not a Combination Product 08/04/2020 7 NDC:79382-002-07 200000 mL in 1 DRUM; Type 0: Not a Combination Product 08/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/04/2020 Labeler - Prime Industries Usa, Inc (117547551)
