Active Ingredient(S)
Benzethonium Chloride 0.13% v/v. Purpose: Antibacterial
Purity Bleu Antibacterial
FDA Label NDC 80955-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alben Internacional, S.a. De C.v. for the product Purity Bleu Antibacterial (NDC 80955-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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
* Please review the disclaimer below.
