Label: CYPRESS BIO-TECH DISINFECTANT HAND WASH- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78804-500-00, 78804-500-01, 78804-500-02 - Packager: Allure Chemicals LP
- 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 March 11, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Use[s]
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Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use: on children less than 2 months of age and open skin wounds.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs.
- Directions
- Inactive Ingredients:
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
CYPRESS BIO-TECH DISINFECTANT HAND WASH
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78804-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYGLYCERYL-10 HEXAOLEATE (UNII: 8S25IPV09I) EDETATE SODIUM (UNII: MP1J8420LU) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALFADEX (UNII: Z1LH97KTRM) ALOE (UNII: V5VD430YW9) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78804-500-01 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2021 2 NDC:78804-500-00 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2021 3 NDC:78804-500-02 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/15/2021 Labeler - Allure Chemicals LP (080442496) Establishment Name Address ID/FEI Business Operations Allure Chemicals LP 080442496 manufacture(78804-500)
