Otc - Active Ingredient
Alcohol 73% v/v. Purpose: Antiseptic.
Colloid 5050 G
FDA Label NDC 79306-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Colloids De Mexico, S.a. De C.v. for the product Colloid 5050 G (NDC 79306-011). 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 otc - active ingredient, 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 tht potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from 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 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 accurs. 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 excesive heat above 40C (104F)
Inactive Ingredient
Purified water USP, Carbomer L, Triethanolamine, Diethanolamine, Monoethanolamine, Monopropylene Glycol.
* Please review the disclaimer below.
