FDA.reportPublic FDA data

Primest Ethyl Alcohol Antiseptic 70

Manufacturer
Prime Lab, LLC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:23:03

Label at a glance#

ProductPrimest Ethyl Alcohol Antiseptic 70
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping Supervise children under 6 years of age when using this product to avoid swallowing

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

  • Health care personnel hand rub to reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Irritation or rash occurs. These may be signs of serious condition

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping
  • Supervise children under 6 years of age when using this product to avoid swallowing

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:79937-007-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79937-00779937-007-01, 79937-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
0fb28392-af4b-9c25-e063-6294a90ace16744e2bd6-38e3-4021-933d-7203da9c3f782024-01-24WarningsExact identifier
spl set id: 744e2bd6-38e3-4021-933d-7203da9c3f78

Reported adverse events (FAERS/openFDA)#

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