Label: FRESH WATER- benzalkonium chloride soap
-
Contains inactivated NDC Code(s)
NDC Code(s): 79147-022-04 - Packager: Spa Dent 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 July 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient.
- Purpose
- Uses
- Warnings
- Directions
- Other Information
-
Inactive Ingredients
Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).
- Questions or comments ?
- PDP04
-
INGREDIENTS AND APPEARANCE
FRESH WATER
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79147-022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 130 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) GLYCERIN (UNII: PDC6A3C0OX) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCO MONOETHANOLAMIDE (UNII: C80684146D) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM SULFATE (UNII: 0YPR65R21J) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79147-022-04 1660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/13/2021 Labeler - Spa Dent Inc (203478896) Registrant - Apollo Health and Beauty Care (201901209) Establishment Name Address ID/FEI Business Operations Spa Dent Inc 203478896 manufacture(79147-022)