Label: HAND SANITIZER- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 77110-270-01, 77110-270-02, 77110-270-03, 77110-270-04, view more77110-270-05, 77110-270-06 - 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.
Drug Label Information
Updated June 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Inactive ingredients
- Use (s)
- Warnings
- Directions
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label
BIOMINERALES
PHARMAHAND SANITIZER - GEL
Kills more than 99.99% of germs
Prevention:
Keep away from heat / sparks / open flames / hot surfaces.
No Smoking. Keep container tightly closed.
Response:
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.
Storage:
Store in a well-ventilated place. Keep cool. Store Between
15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above
40 °C (104 °F)
Disposal:
Dispose of contents / container to an approved waste disposal plant.Active Ingredients: Ethyl Alcohol 70% v/v
NDC: 77110-270-01
Manufactured for and
Distributed by:
Biominerales Pharma, LLC
Boca Raton, Florida 33442
www.biomineralespharma.comNet Contents
1 Gal. (3,785 mL) -
INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77110-270 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77110-270-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 2 NDC:77110-270-06 944 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 3 NDC:77110-270-02 472 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 4 NDC:77110-270-03 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 5 NDC:77110-270-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 6 NDC:77110-270-05 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 06/15/2020 Labeler - Biominerales Pharma, LLC (117489663) Establishment Name Address ID/FEI Business Operations Biominerales Pharma, LLC 117489663 MANUFACTURE(77110-270)