Label: PURITY BLEU ANTIBACTERIAL- benzalkonium chloride solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 80955-010-01, 80955-010-02 - Packager: Alben Internacional, 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 October 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
-
WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
-
Inactive ingredients
WATER, SODIUM LAURYL ETHER SULFATE, COCAMIDOPROPYL BETAINE, COCAMIDE DIETHANOLAMINE, GLYCERIN, ALOE BARBADENSIS EXTRACT, FRAGRANCE, BENZOPHENONE-4, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, Can Contain: RED No. 40 (CI 16035), RED No. 33 (CI 17200), BLUE No. 1 (CI 42090), YELLOW No. 5 (CI 19140), GREEN No. 3 (CI 42053), VIOLET 2 (CI 60730)
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
PURITY BLEU ANTIBACTERIAL
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80955-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 13 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) BENZOPHENONE-5 (UNII: 853Z42ZYAS) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) COCO DIETHANOLAMIDE (UNII: 92005F972D) GLYCERIN (UNII: PDC6A3C0OX) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80955-010-01 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 2 NDC:80955-010-02 1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Alben Internacional, S.A. de C.V. (813978616) Registrant - Alben Internacional, S.A. de C.V. (813978616) Establishment Name Address ID/FEI Business Operations Alben Internacional, S.A. de C.V. 813978616 manufacture(80955-010)
