FDA.reportPublic FDA data

Assured

Manufacturer
SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD.
Effective date
2013-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:34:13

Label at a glance#

ProductAssured
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Water

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Isopropyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses

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

For preparation of the skin prior to injection

WARNINGS SECTION

Warnings

For external use only

Flammable. Keep away from fire or flame

DOSAGE & ADMINISTRATION SECTION

Directions

Apply to skin as needed

Discard after single use

OTC - DO NOT USE SECTION

Do not use

-in contact with eyes or with mucous membranes

-more than 7 days unless directed by a doctor

-over large areas of the body

-on deep or puncture wounds, animal bites or serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

-excessive irritation and redness develop

-condition gets worse or persists for more than 7 days

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55310-001-012020-01-31C16284748780-19d75b9d0-3bd4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55310-001-01Assured300 mL in 1 POUCHPATCH3003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55310-001ASSURED (ISOPROPYL ALCOHOL) PATCH [SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD.]3Legacy NDC, 1 package rows20130110_e909eb0b-bc55-41e5-82e2-0edcfd160e6c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163023
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163023
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55310-00155310-001-01

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
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
92cccc28-94a8-4b0d-9d46-94b1b7374e7de909eb0b-bc55-41e5-82e2-0edcfd160e6c2013-01-09WarningsExact identifier
spl id: 92cccc28-94a8-4b0d-9d46-94b1b7374e7d
spl set id: e909eb0b-bc55-41e5-82e2-0edcfd160e6c

Reported adverse events (FAERS/openFDA)#

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