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DRUG FACTS
Manufactured by:
Biominerales Pharma, LLC
150 E Palmetto Park Rd
Boca Raton, FL 33432
Advanced Protection Hand Sanitizing
FDA Label NDC 77110-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biominerales Pharma for the product Advanced Protection Hand Sanitizing (NDC 77110-700). 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 other, active ingredients, purpose, inactive ingredients, use (s), cautions and warnings, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Isopropyl alcohol – 70% v/v
Purpose
Antiseptic
Inactive Ingredients
Deionized water, Carbomer, Propylene Glycol, Triethanolamine,Hydrogen Peroxide.
Use (S)
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when water and soap are not available.
Cautions And Warnings
- For external use only
- Flammable
- Keep away from heat or flame
- Keep out of reach of children
Otc - Do Not Use
- Do not use in children less than 2 months of age or on open skin wounds
Otc - When Using
- When using this product keep our of eyes, ears and mouth.
In case of contact with eyes, rinse eyes thoroughly with water
- 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 poison control center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs
Directions
Rub thoroughly into hands for at least 30 seconds, allow to dry.
Supervise children when they use this product.
Adults and children 2 years and older:
For occasional and personal domestic use.
Other Information
Store Between 15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above 40 °C (104 °F).
Principal Display Panel - 3,785 Ml Container Label
ADVANCED PROTECTION
HAND SANITIZING GEL
BIOMINERALES PHARMA
KILLS HARMFUL BACTERIA/GERMS
1 Gallon
(3,785ml)
70%
v/v
ISOPROPYL
ALCOHOL
Principal Display Panel (3,785 ml Container Label)
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