Label: ADVANCED HAND SANITIZER- alcohol gel
- NDC Code(s): 77110-100-01
- Packager: Biominerales Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 6, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (s)
For external use only. Flammable. Keep away from heat or flame
Do not use
- Children under 6 years of a age should be supervise when using this product
- 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.
- OTHER INFORMATION
- Inactive Ingredients
PRINCIPAL DISPLAY PANEL - 3785 ML Bottle Label
Kills more than 99.99% of germs
Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
Keep container tightly closed.
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing. If eye
irritation persists: Get medical advice/ attention. In case of fire: Use
dry sand, dry chemical or alcohol-resistant foam for extinction.
Store in a well-ventilated place. Keep cool.
Dispose of contents/ container to an approved waste disposal plant.
Ethyl Alcohol 80%
Hydrogen Peroxide .125%
Sterilized water 18.425%
Net Contents 3785 ML
Made in the USA
INGREDIENTS AND APPEARANCE
ADVANCED HAND SANITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77110-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.8 mL in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.0145 mL in 1 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.18425 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77110-100-01 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 05/10/2020 Labeler - Biominerales Pharma, LLC (117489663) Establishment Name Address ID/FEI Business Operations Biominerales Pharma, LLC 117489663 MANUFACTURE(77110-100)