ROYAL ALCOHOL CLEANSING- isopropyl alcohol patch

Royal Alcohol Cleansing by

Drug Labeling and Warnings

Royal Alcohol Cleansing by is a Otc medication manufactured, distributed, or labeled by Filo America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

ROYAL ALCOHOL CLEANSING 
isopropyl alcohol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50435-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50435-200-00	100 in 1 BOX	11/13/2017
1		5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/11/2017

Labeler - Filo America (943873703)