Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Pacific Gel
FDA Label NDC 79058-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ad Medios & Mkt, S.a. De C.v. for the product Pacific Gel (NDC 79058-002). 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
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
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
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
polyacrylic acid (Carbomer), triethanolamine (Trolamine), water
Package Label.Principal Display Panel
60 mL (60 mL Baja)
250 mL (250 mL Baja)
500 mL (500ml Etiqueta Pacificgel Baja)
1000 mL (1litro Etiqueta Pacificgel Baja)
3785 mL (3.785l Etiqueta Pacificgel Baja)
20 L (20l Etiqueta Pacificgel Baja)
200 L (200l Etiqueta Pacificgel Baja)
5000 ml NDC: 79058-002-06
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