FDA.reportPublic FDA data

Previcare Hyssop Sanitizer Gel

Manufacturer
Previcare Pharmaceutical, Inc.
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:07

Label at a glance#

ProductPrevicare Hyssop Sanitizer
Active ingredientAlcohol
Label structure12 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

Dosage and administration

Apply to one palm, rub hands together until dry. Use as part of your daily cleaning routine. Do not rinse with water. Do not dilute the product. Supervise children when using this product.

Storage and handling

Store at 50-86°F (15-30°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% V/V

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame. Do not ingest. Do not use if you are allergic to any ingredient.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help. Do not use on open wounds. When using ths product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. Stop use and ask a doctor if irritation develops.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to one palm, rub hands together until dry. Use as part of your daily cleaning routine. Do not rinse with water. Do not dilute the product. Supervise children when using this product.

Other Information

STORAGE AND HANDLING SECTION

Store at 50-86°F (15-30°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (purified water), Hyssop and Rosemary Mint Oil, Glycerin, Aloe Barbadensis (Aloe) Leaf Juice, PEG-75 Lanolin, PEG-7 Glyceryl Cocoate (emollient), Myristyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine.

Questions?

OTC - QUESTIONS SECTION

Call 1 (716) 427-7979

SPL UNCLASSIFIED SECTION

Distributed by: Previcare Pharmaceutical, Inc.
50 Fountain Plaza • Suite 1400 • Buffalo • NY • 14202 • USA

PRINCIPAL DISPLAY PANEL - 60 ML Bottle Label - NDC 73401-849

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREVICARE
SANITIZER GEL | 70% ALCOHOL

HYSSOP

2 FL OZ (60 ML)

NDC 73401-849-09

Principal Display Panel - 60 ML Bottle Label - NDC 73401-849
Principal Display Panel - 60 ML Bottle Label - NDC 73401-849

PRINCIPAL DISPLAY PANEL - 60 ML Bottle Label - NDC 73401-850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREVICARE
SANITIZER GEL | 70% ALCOHOL

HOLY WATER
+ HYSSOP

2 FL OZ (60 ML)

NDC 73401-850-09

Principal Display Panel - 60 ML Bottle Label - NDC 73401-850
Principal Display Panel - 60 ML Bottle Label - NDC 73401-850

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73401-849-092023-07-28C16284748780-10191ceaa-6458-198a-e063-dbdaa90aec3ePrevicare Hyssop Sanitizer Gel
73401-849-102023-07-28C16284748780-10191ceaa-6458-198a-e063-dbdaa90aec3ePrevicare Hyssop Sanitizer Gel
73401-850-092023-07-28C16284748780-10191ceaa-6458-198a-e063-dbdaa90aec3ePrevicare Hyssop Sanitizer Gel
73401-850-102023-07-28C16284748780-10191ceaa-6458-198a-e063-dbdaa90aec3ePrevicare Hyssop Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73401-849-09Previcare Hyssop Sanitizer60 mL in 1 BOTTLEGEL601
73401-849-10Previcare Hyssop Sanitizer60 mL in 1 BOTTLEGEL601
73401-850-09Previcare Holy Water plus Hyssop Sanitizer60 mL in 1 BOTTLEGEL601
73401-850-10Previcare Holy Water plus Hyssop Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73401-849PREVICARE HYSSOP SANITIZER (ALCOHOL) GEL PREVICARE HOLY WATER PLUS HYSSOP SANITIZER (ALCOHOL) GEL [PREVICARE PHARMACEUTICAL, INC.]1Legacy NDC, 2 package rows20210215_41d97ec1-4c15-4187-8123-fa3e78156de7.zip
73401-850PREVICARE HYSSOP SANITIZER (ALCOHOL) GEL PREVICARE HOLY WATER PLUS HYSSOP SANITIZER (ALCOHOL) GEL [PREVICARE PHARMACEUTICAL, INC.]1Legacy NDC, 2 package rows20210215_41d97ec1-4c15-4187-8123-fa3e78156de7.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73401-84973401-849-09, 73401-849-10
73401-85073401-850-09, 73401-850-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PEG-75 LANOLIN09179OX7TBIACT
MYRISTYL ALCOHOLV42034O9PUIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
HYSSOP OIL173D71924BIACT
Alcohol3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PEG-75 LANOLIN09179OX7TBIACT
MYRISTYL ALCOHOLV42034O9PUIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
HYSSOP OIL173D71924BIACT

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
a16aaf24-d40c-4b9b-9bee-773c57ba749d41d97ec1-4c15-4187-8123-fa3e78156de72021-02-10WarningsExact identifier
spl id: a16aaf24-d40c-4b9b-9bee-773c57ba749d
spl set id: 41d97ec1-4c15-4187-8123-fa3e78156de7

Reported adverse events (FAERS/openFDA)#

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