FDA.reportPublic FDA data

Pharmadel

Manufacturer
Pharmadel LLC
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:52:13

Label at a glance#

ProductPharmadel First Aid Antiseptic
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Indications and uses

First aid to help prevent the risk of infection in minor cuts scrapes burns

Dosage and administration

clean the affected area apply a small amount of this product on the affected area 1 to 3 times daily may cover area with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Isopropyl alcohol 70% ...........First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of infection in

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. If taken internally, it will cause serious gastric disturbances.

Flammable: Keep away from fire or flame, heat, spark, electrical

Do not use

OTC - DO NOT USE SECTION

  • longer than 1 week, unless directed by a doctor
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product on the affected area 1 to 3 times daily
  • may cover area with a sterile bandage
  • if bandaged, let dry first

Other information

OTHER SAFETY INFORMATION

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • do not use if foil under cap is torn, broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water

Dist. by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC.

650 Centerpoint Blvd

New Castle, DE 19720

www.pharmadel.com

+1-866-359-3478

Made in India

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WARNING FLAMMABLE:

KEEP AWAY FROM HEAT, SPARK, ELECTRICAL, FIRE OR FLAME.

Use only in a well-ventilated area; fumes can be harmful.

PHDIA70PDPPHDIA70PDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-422PHARMADEL FIRST AID ANTISEPTIC (ISOPROPYL ALCOHOL 70%) LIQUID [PHARMADEL LLC]3Unmatched20241017_1aa1869f-ba35-2f70-e063-6394a90acc88.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-42255758-422-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
437f9433-775c-63d6-e063-6394a90ad0141aa1869f-ba35-2f70-e063-6394a90acc882025-11-13WarningsExact identifier
spl set id: 1aa1869f-ba35-2f70-e063-6394a90acc88

Reported adverse events (FAERS/openFDA)#

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