FDA.reportPublic FDA data

PREMIER PURE Protection

Manufacturer
RPP PRODUCTS, INC.
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:53

Label at a glance#

ProductPREMIER PURE Protection
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

hand sanitizer to help reduce bacteria on the skin 

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. children under 6 years of age should be supervised when using this PREMIER PURE

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 72% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce bacteria on the skin 

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame

For external use only

When using this product do not use in or near the eyes

In case of contact rinse thoroughly with water 

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

irritation or rash appears and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help right away or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • children under 6 years of age should be supervised when using this PREMIER PURE

Other information

OTHER SAFETY INFORMATION

  • Store below 1100 F (430C)
  •  May discolor certain fabrics or surfaces 
  • This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Ethanolamine, Carbomer, Propylene Glycol, Fragrance, Citric Acid

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN1
2277550ethanol 0.72 ML/ML Topical GelSCD1
2277550ethanol 72 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73945-004-012022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-022022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-032022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-042022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-052022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-062022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-072022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-082022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-092022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-102022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-112022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46
73945-004-122022-01-28C16284748780-1d6a99b39-7152-a426-e053-dadaa90af4c23c11775e-0032-45ef-982c-1d3b78b00f46

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73945-004-01PREMIER PURE Protection59 mL in 1 BOTTLE, PLASTICGEL591
73945-004-02PREMIER PURE Protection88.72 mL in 1 BOTTLE, PLASTICGEL88.721
73945-004-03PREMIER PURE Protection118.3 mL in 1 BOTTLE, PLASTICGEL118.31
73945-004-04PREMIER PURE Protection236.59 mL in 1 BOTTLE, PLASTICGEL236.591
73945-004-05PREMIER PURE Protection295.74 mL in 1 BOTTLE, PLASTICGEL295.741
73945-004-06PREMIER PURE Protection354.88 mL in 1 BOTTLE, PLASTICGEL354.881
73945-004-07PREMIER PURE Protection443.17 mL in 1 BOTTLE, PLASTICGEL443.171
73945-004-08PREMIER PURE Protection946 mL in 1 BOTTLE, PLASTICGEL9461
73945-004-09PREMIER PURE Protection1890 mL in 1 BOTTLE, PLASTICGEL18901
73945-004-10PREMIER PURE Protection2000 mL in 1 BOTTLE, PLASTICGEL20001
73945-004-11PREMIER PURE Protection2800 mL in 1 BOTTLE, PLASTICGEL28001
73945-004-12PREMIER PURE Protection3780 mL in 1 BOTTLE, PLASTICGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73945-004PREMIER PURE PROTECTION (ETHYL ALCOHOL) GEL [RPP PRODUCTS, INC.]1Legacy NDC, 12 package rows20200507_3c11775e-0032-45ef-982c-1d3b78b00f46.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73945-00473945-004-01, 73945-004-02, 73945-004-03, 73945-004-04, 73945-004-05, 73945-004-06, 73945-004-07, 73945-004-08, 73945-004-09, 73945-004-10, 73945-004-11, 73945-004-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MONOETHANOLAMINE5KV86114PTIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML · Source PDF

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
8f25edb6-72e1-4884-9687-f1fc00f026673c11775e-0032-45ef-982c-1d3b78b00f462020-05-05WarningsExact identifier
spl id: 8f25edb6-72e1-4884-9687-f1fc00f02667
spl set id: 3c11775e-0032-45ef-982c-1d3b78b00f46

Reported adverse events (FAERS/openFDA)#

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