FDA Label for Puregel Hand Sanitizer Gel
View Indications, Usage & Precautions
Puregel Hand Sanitizer Gel Product Label
The following document was submitted to the FDA by the labeler of this product Xma Servicios De Manufactura S De Rl De Cv. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is a hand sanitizer manufactured according to the Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020).
The hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product, with percentages iof the active ingredient consistent with the above mentioned final rule, Isopropyl Alcohol (70%, v/v).
Otc - Active Ingredient
Isopropyl Alcohol 70% v/v. Purpose: Antiseptic
Otc - Purpose
Hand Sanitizer
Indications & Usage
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
Otc - 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.
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.
Dosage & Administration
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.
Storage And Handling
-Store between 15-30C (59-86F)
-Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
glycerin, purified water USP, carbomer, trolamine
Package Label.Principal Display Panel
60 ml NDC: 78108-1705-1 330 ml NDC: 78108-1705-3 1 L NDC: 78108-1705-5 1 Gallon NDC: 78108-1705-8
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