FDA.reportPublic FDA data

HAND SANITIZING

Manufacturer
Biominerales Pharma
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:37

Label at a glance#

ProductHAND SANITIZING
Active ingredientIsopropyl alcohol
Label structure10 sections

Dosage and administration

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.

Storage and handling

Store Between 15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above 40 °C (104 °F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol – 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized water, Carbomer, Propylene Glycol, Triethanolamine, Hydrogen Peroxide.

Use (s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when water and soap are not available.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store Between 15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above 40 °C (104 °F).

Cautions and warnings

WARNINGS SECTION

  • For external use only
  • Flammable
  • Keep away from heat or flame
  • Keep out of reach of children

OTC - DO NOT USE SECTION

  • Do not use in children less than 2 months of age or on open skin wounds

OTC - WHEN USING SECTION

  • 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 SECTION

  • Keep out of reach of children
  • If swallowed, get medical help or contact poison control center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

SPL UNCLASSIFIED SECTION

Manufactured by:
Hempire Farms, LLC
150 E Palmetto Park Rd
Boca Raton, FL 33432

PRINCIPAL DISPLAY PANEL - 473 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

USA
HEMPIRE
FARMS

MADE IN
USA

KILLS HARMFUL BACTERIA/GERMS

16 fl. Oz. (473 mL)

HAND SANITIZING GEL with
HEMP OIL & ALOE for moisturizing

16 fl. oz.
(473 mL)

70 %
v/v
ADVANCED

ISOPROPYL
ALCOHOL
PROTECTION

PRINCIPAL DISPLAY PANEL - 473 mL Container Label
PRINCIPAL DISPLAY PANEL - 473 mL Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN1
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD1
581698isopropyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77110-600-012022-01-28C16284748780-1d6a99b39-5fe2-a426-e053-dadaa90af4c2HAND SANITIZING
77110-600-022022-01-28C16284748780-1d6a99b39-5fe2-a426-e053-dadaa90af4c2HAND SANITIZING
77110-600-032022-01-28C16284748780-1d6a99b39-5fe2-a426-e053-dadaa90af4c2HAND SANITIZING
77110-600-042022-01-28C16284748780-1d6a99b39-5fe2-a426-e053-dadaa90af4c2HAND SANITIZING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77110-600-01HAND SANITIZING3785 mL in 1 CONTAINERGEL37851
77110-600-02HAND SANITIZING946 mL in 1 CONTAINERGEL9461
77110-600-03HAND SANITIZING473 mL in 1 CONTAINERGEL4731
77110-600-04HAND SANITIZING236 mL in 1 CONTAINERGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77110-600HAND SANITIZING (ISOPROPYL ALCOHOL) GEL [BIOMINERALES PHARMA]1Legacy NDC, 4 package rows20200903_2ff3d532-1dee-4cfb-8852-20f654fb8b61.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77110-60077110-600-04, 77110-600-03, 77110-600-02, 77110-600-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Isopropyl alcoholND2M416302ACTIB
Water059QF0KO0RIACT
Carbomer Homopolymer, Unspecified Type0A5MM307FCIACT
Propylene Glycol6DC9Q167V3IACT
Trolamine9O3K93S3TKIACT
Hydrogen PeroxideBBX060AN9VIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bc321917-986d-4a5e-b779-86cb7171090d2ff3d532-1dee-4cfb-8852-20f654fb8b612020-09-02WarningsExact identifier
spl id: bc321917-986d-4a5e-b779-86cb7171090d
spl set id: 2ff3d532-1dee-4cfb-8852-20f654fb8b61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.