Otc - Active Ingredient
Alcohol %70 (%96,4 volume) v/v Purpose: Antiseptic
Blutizer Hand Sanitizer Gel
FDA Label NDC 77184-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Campusorg Turizm Organizasyon Reklamcilik Pazarlama Sanayi Ve Ticaret Limited Sirketi for the product Blutizer Hand Sanitizer Gel (NDC 77184-135). 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 in specific populations, 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 In Specific Populations
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 of 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 warter.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious contiditon.
Keep our of reac 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.
Dosage & Administration
Place enough product on hands to cover all surfaces. Rub hand together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Storage And Handling
Store between 15-43C (59-110F)
Avoid freezing and excessive heat above 43C (110F)
Inactive Ingredient
- Isopropyl Alcohol %3 (Purpose: Antiseptic and Anti-Foaming)
- Glycerin (Purpose: Humidifier)
- Hydrogen Peroxide (Purpose: Sterilizing)
- Propylene Glycol
- Isopropyl Myristate
- Trolamine
- Carbomer
- Prufied Water USP (Purpose: Solvent)
Package Label.Principal Display Panel
1000 mL (33 fl oz) NDC: 77184-135-11
1 Lt Label (Bulutizer Etiket Kucuk)
1 Lt Bottle With Regular Cap (Pompasiz 1 Lt Sise Kucuk)
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