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NDC 36800-0864-43 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 TopCo Associates. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	36800-0864
Product ID	36800-864_050b4ae2-520c-4549-9fc4-0eabe8f446a8
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	TopCo Associates
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 36800-0864-43 (36800086443)

Pricing Information	N/A
NDC Package Code	36800-864-43
Billing NDC	36800086443
Package	473 mL in 1 BOTTLE, PLASTIC (36800-864-43)
Marketing Start Date	2017-04-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7054bb7b-d16f-46fd-a3d4-481a8da047fd Details

Active ingredient

Isopropyl alcohol 50%

Purpose

First aid antiseptic

Use

helps prevent the risk of infection in:

minor cuts
scrapes
burns

Warnings

For external use only

Flammable

keep away from fire or flame, heat spark, electrical

Ask a doctor before use

If you have deep or puncture wounds, animal bites or serious burns

When using this product

do not get into eyes
do not apply over large areas of the body
do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor

if condition persists or gets worse

keep out of children

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

For Rubbing & Massaging

Caution - do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes.

Directions

clean the affected area
apply a small amount of this 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
will produce serious gastric distrubances if taken internally

Inactive ingredient

water

adverse reaction

DIST. BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

1-888-423-0139 [email protected] www.topcarebrands.com

principal display panel

TopCare

health

50%

Isopropyl

Alcohol

FIRST AID ANTISEPTIC

Helps Preven the Risk of Infection in:

Minor Cuts
Minor Scrapes
Minor Burns

OUR PHARMACISTS RECOMMEND

WARNING FLAMMABLE: Keep away from heat, spark, electrical fire or flame

Use only in a well-ventilated area: fumes can be harmful.

CAUTION: Do not point at self or others, product will squirt when squeezed

Visit here for more information:

http://topbrnds.com

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:36800-864
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:36800-864-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/03/2017

Labeler - TopCo Associates (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-864)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-864)

Revised: 6/2022

Document Id: 050b4ae2-520c-4549-9fc4-0eabe8f446a8

Set id: 7054bb7b-d16f-46fd-a3d4-481a8da047fd

Version: 13

Effective Time: 20220609