Active Ingredient
Ethyl Alcohol 70%
Dermonano
FDA Label NDC 75751-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pgh Laboratorios Do Brasil Ltda. for the product Dermonano (NDC 75751-070). 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, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, 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
Use
Hand rub to help reduce bacteria that potentially can cause disease when water is 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.
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
Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine
Questions Or Comments
Principal Display Panel
NDC: 75751-070-04
Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM
Gel 70% (alcohol)
Sanitation Effective against bacteria and germs
Requires no water
Danger: Flammable
Keep out of reach of children
Keep away from fire or flame
For external use only
See other cautions on opposite panel of label
Net Wt. 120g e 4.2 oz
Label (4)
NDC: 75751-070-16
Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM
Gel 70% (alcohol)
Sanitation Effective against bacteria and germs
Requires no water
Danger: Flammable
Keep out of reach of children
Keep away from fire or flame
For external use only
See other cautions on opposite panel of label
Gel 70% (alcohol)
Net Wt. 480g e 16.9 oz
Label 1 (16)
NDC: 75751-070-26
Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM
Gel 70% (alcohol)
Sanitation Effective against bacteria and germs
Requires no water
Danger: Flammable
Keep out of reach of children
Keep away from fire or flame
For external use only
See other cautions on opposite panel of label
Gel 70% (alcohol)
Net Wt. 1000L e 33814oz
Label 2 (26)
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