FDA.reportPublic FDA data

Alcohol

Manufacturer
Dalian Rongbang Medical Healthy Devices Co., Ltd.
Effective date
2016-11-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:48:04

Label at a glance#

ProductAlcohol
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Two swabsticks saturated with 70% isopropyl alcohol.


Apply swabstick to skin.

INACTIVE INGREDIENT SECTION

water

INDICATIONS & USAGE SECTION

To clean injection and other catheter sites.

Apply swabstick to skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

<Hospital professional use>

WARNINGS SECTION

For external use only

Discard after single use

OTC - PURPOSE SECTION

<To clean injection and other catheter sites.>


OTC - ACTIVE INGREDIENT SECTION

isopropyl alcohol 70 %

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol Swab 3-pc FrontAlcohol Swab 3-pc FrontAlcohol Swab 3-pc backAlcohol Swab 3-pc backAlcohol Swab FrontAlcohol Swab FrontAlcohol Swab BackAlcohol Swab Back<alcohol swabsticks saturated with 70% isopropyl alcohol, for professional and hosptial use>

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD7
797544isopropyl alcohol 70 % Medicated PadSY7
797544isopropyl alcohol 70 % Topical ClothSY7
797544isopropyl alcohol 70 % Topical SwabSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49953-2801-22020-01-31C16284748780-19d75b9d0-b9aa-f424-e053-dadaa90a57ceAlcohol Swabsticks
49953-2801-32020-01-31C16284748780-19d75b9d0-b9aa-f424-e053-dadaa90a57ceAlcohol Swabsticks

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49953-2801-2Alcohol1 mL in 1 POUCHSWAB17
49953-2801-3Alcohol3 mL in 1 POUCHSWAB37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49953-2801ALCOHOL (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES CO., LTD.]7Legacy NDC, 2 package rows20161129_04191cac-54e5-41ce-95fb-b8d24e1f40b6.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
49953-280149953-2801-2, 49953-2801-3

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
42669cda-156e-4181-e054-00144ff8d46c04191cac-54e5-41ce-95fb-b8d24e1f40b62016-11-28WarningsExact identifier
spl id: 42669cda-156e-4181-e054-00144ff8d46c
spl set id: 04191cac-54e5-41ce-95fb-b8d24e1f40b6

Reported adverse events (FAERS/openFDA)#

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