PURITY BLEU ANTIBACTERIAL- benzalkonium chloride solution 
Alben Internacional, S.A. de C.V.

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.

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Active Ingredient(s)

Benzethonium Chloride 0.13% v/v. Purpose: Antibacterial

Purpose

Antibacterial, Hand Soap

Use

Uses - For handwashing to decrease bacteria on the skin

Warnings

For external use only.

Do not use

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 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.

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

250 ml NDC:80955-010-01

250

1000 ml NDC:80955-010-02

1000

PURITY BLEU ANTIBACTERIAL 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80955-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80955-010-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
2NDC:80955-010-021000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Alben Internacional, S.A. de C.V. (813978616)
Registrant - Alben Internacional, S.A. de C.V. (813978616)
Establishment
NameAddressID/FEIBusiness Operations
Alben Internacional, S.A. de C.V.813978616manufacture(80955-010)

Revised: 10/2020
Document Id: b2beb979-8fc3-9842-e053-2995a90ae5f9
Set id: b2beb979-8fd1-9842-e053-2995a90ae5f9
Version: 1
Effective Time: 20201028
 
Alben Internacional, S.A. de C.V.