ROYAL ALCOHOL CLEANSING- isopropyl alcohol patch 
Filo America

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Royal Alcohol Cleansing pads

Drug Facts

Active Ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

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

Warning:

For external use only

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Caution do not apply to irritated skin.

Do not ues

in the eyes or on mucous membranes. In case of deep cuts or puncture wounds, consult a doctor.

Directions

wipe injection site vigorously.

Other information

store at room temperature.

Inactive ingredient

water.

Package Labeling:

Label

Box

ROYAL ALCOHOL CLEANSING 
isopropyl alcohol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50435-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50435-200-00100 in 1 BOX11/13/2017
15 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/11/2017
Labeler - Filo America (943873703)

Revised: 3/2023
Document Id: f68ed878-971b-4e0e-e053-2995a90a9ccc
Set id: 3849170d-63cd-42f4-8422-c9f003c8ed0c
Version: 3
Effective Time: 20230310
 
Filo America