Dr. Pure True Sanitizer Antiseptic Hand Sanitizer

Dr. Pure True Sanitizer Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Dr. Pure True Sanitizer Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Industrias Bernal Cantón, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. PURE TRUE SANITIZER ANTISEPTIC HAND SANITIZER- alcohol liquid 
Industrias Bernal Cantón, 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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Dr. Pure True Sanitizer Antiseptic Hand Sanitizer

Drug Facts

Active ingredient 

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin. 

Warnings

For external use only.

Flammable, keep away from fire and flame. 

Do not use

in the eyes.

Stop use and ask a doctor if

• Irritation and redness develop.
• Condition persists for more than 72 hours. 

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping. 

Inactive ingredients 

Benzalkonium chloride, EDTA, glycerin, water. 

Questions or comments?

210-202-2366.

Package Labeling: 78239-010-01

DR. PURE TRUE SANITIZER ANTISEPTIC HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78239-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	750 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78239-010-01	1 in 1 BOX	08/31/2022	04/01/2023
1		300 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/31/2022	04/01/2023

Labeler - Industrias Bernal Cantón, S.A. de C.V. (812827340)

Revised: 3/2023

Document Id: f76ddcb2-becd-e012-e053-6294a90a48dd

34390-5

Set id: b8155b4c-475f-4257-93c8-5082d2a504ec

Version: 2

Effective Time: 20230321