ROYAL ALCOHOL CLEANSING PADS

Manufacturer: Filo America
Effective date: 2013-07-31
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:36:22

Label at a glance#

ProductROYAL ALCOHOL CLEANSING PADS

Active ingredientISOPROPYL ALCOHOL

Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for the preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.

Warning:

WARNINGS SECTION

For external use only

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 immediately.

Caution

OTC - STOP USE SECTION

do not apply to irritated skin.

Do not use

OTC - DO NOT USE SECTION

in the eyes or on mucous membranes.

In case

OTC - ASK DOCTOR SECTION

of deep cuts or puncture wounds, consult a doctor.

Direction

DOSAGE & ADMINISTRATION SECTION

wipe injection site vigorously.

Other information

SPL UNCLASSIFIED SECTION

store at room temperature.

Inactive ingredient

INACTIVE INGREDIENT SECTION

water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROYAL ALCOHOL CLEANSING PADS

PRE-MOISTENED WIPES FOR EVERYDAY USE

Individually foil wrapped
70% Isopropyl Alcohol

100 INDIVIDUAL PACKS
SAFE AND EAST TO USE
STERILE unless individual wrapper is opened or damaged.

ROYAL ALCOHOL CLEANSING PADS 100 Packs (50438-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
797544	isopropyl alcohol 70 % Medicated Pad	PSN	2
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	2
797544	isopropyl alcohol 70 % Medicated Pad	SY	2
797544	isopropyl alcohol 70 % Topical Cloth	SY	2
797544	isopropyl alcohol 70 % Topical Swab	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50438-000-00	2019-11-27	C162847	48780-1	9855d018-da03-cd31-e053-dbdaa90ab51a	ROYAL ALCOHOL CLEANSING PADS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50438-000-00	ROYAL ALCOHOL CLEANSING PADS	100 in 1 PACKAGE	LIQUID	100		2
50438-000-00	ROYAL ALCOHOL CLEANSING PADS	0.45 g in 1 PACKET	LIQUID	0.45		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50438-000	ROYAL ALCOHOL CLEANSING PADS (ISOPROPYL ALCOHOL) LIQUID [FILO AMERICA]	2	Legacy NDC, 2 package rows	20130731_18b3c907-b85c-4c90-8840-d8ec79a6a567.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	2
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

ROYAL ALCOHOL CLEANSING PADS
ISOPROPYL ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50438-000	50438-000-00

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
Name	UNII	Kind
ISOPROPYL ALCOHOL	ND2M416302	ACTIB
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
59010069-606b-4b93-b56e-653c6eae3a27			18b3c907-b85c-4c90-8840-d8ec79a6a567	2013-07-31	Warnings	Exact identifier spl id: 59010069-606b-4b93-b56e-653c6eae3a27 spl set id: 18b3c907-b85c-4c90-8840-d8ec79a6a567

Reported adverse events (FAERS/openFDA)#

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