PURITY BLEU ANTIBACTERIAL- benzalkonium chloride solution

Purity Bleu Antibacterial by

Drug Labeling and Warnings

Purity Bleu Antibacterial by is a Otc medication manufactured, distributed, or labeled by Alben Internacional, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age
• on open skin wounds

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Directions - pump into DRY hands - lather vigorously for at least 15 seconds - rinse and dry thoroughly
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

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

1000 ml NDC: 80955-010-02

INGREDIENTS AND APPEARANCE

PURITY BLEU ANTIBACTERIAL 
benzalkonium chloride solution

Product 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)