BY Pure by Iron Lab, S.A. de C.V.

BY Pure by

Drug Labeling and Warnings

BY Pure by is a Otc medication manufactured, distributed, or labeled by Iron Lab, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BY PURE- ethyl alcohol gel 
Iron Lab, 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)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• 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,triethanolamine, propylene glycol, carbomer

Package Label - Principal Display Panel

1000 mL NDC: 74375-001-01

1800 mL NDC: 74375-001-02

500 mL NDC: 74375-001-03

BY PURE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74375-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74375-100-01	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/28/2021	07/30/2021
2	NDC: 74375-100-02	1800 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/28/2021	07/30/2021
3	NDC: 74375-100-03	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/28/2021	07/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	07/30/2021

Labeler - Iron Lab, S.A. de C.V. (951575800)

Registrant - Iron Lab, S.A. de C.V. (951575800)

Establishment
Name	Address	ID/FEI	Business Operations
Iron Lab, S.A. de C.V.		951575800	manufacture(74375-100)

Revised: 8/2021

Document Id: c95ed409-80f2-0d82-e053-2a95a90a8cbb

34390-5

Set id: b9f98de4-852b-01fc-e053-2a95a90a3ca5

Version: 3

Effective Time: 20210812