Search by Drug Name or NDC

NDC 50804-0864-43 50% Rubbing 500 mg/mL Details

50% Rubbing 500 mg/mL

50% Rubbing is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	50804-0864
Product ID	50804-864_14df19b7-e9c9-480e-a5f8-43236220f679
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	50% Rubbing
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	500
Active Ingredient Units	mg/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Perrigo Direct, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0864-43 (50804086443)

Pricing Information	N/A
NDC Package Code	50804-864-43
Billing NDC	50804086443
Package	473 mL in 1 BOTTLE, PLASTIC (50804-864-43)
Marketing Start Date	2010-05-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 698bede7-4fc1-4e85-8ac4-d735f409cfae Details

Active ingredient

Isopropyl alcohol 50%

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in:

minor cuts
scarapes
burns

Warnings

For external use only. If taken internally serious gastric disturbances will result.

Flammable

Keep away from fire or flame, heat, spark, electrical

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

When using this product

do not get into eyes
do not inhale
do not apply over large areas of the body
do not use longer than 1 week

Stop use and ask a doctor if

condition persists or gets worse

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Caution

Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

Directions

clean the affected area
apply a small amount of the is product on the affected area 1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Other Information

does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredient

water

SPL UNCLASSIFIED SECTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, Ga 30269

www.PerrigoDirect.com

1-888-593-0593

Pat. D675, 101

principal display panel

NDC 50804-864-43

GOODSENSE

50%

Isopopyl

Alcohol

First Aid Antiseptic
For Rubbing and Massaging

WARNING FLAMMABLE - Keep away from hear, spark, electrical, fire or flame

Use only in well-ventilated area;

fumes can be harmful

CAUTION: Do not point at self or

others; product will squirt when sqeezed.

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

50% RUBBING

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-864
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	500 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-864-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/21/2010

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-864)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-864)

Revised: 10/2022

Document Id: 14df19b7-e9c9-480e-a5f8-43236220f679

Set id: 698bede7-4fc1-4e85-8ac4-d735f409cfae

Version: 11

Effective Time: 20221006