ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN- isopropyl alcohol liquid

Isopropyl Rubbing Alcohol 50% with Wintergreen by

Drug Labeling and Warnings

Isopropyl Rubbing Alcohol 50% with Wintergreen by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (by volume)

Isopropyl alcohol (50% conc.)

PURPOSE

Purpose

First aid antiseptic

INDICATIONS & USAGE

Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes and burns

WARNINGS

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical

ASK DOCTOR

Ask a doctor before use if you have

• deep punctured wounds, animal bites or serious burns

WHEN USING

When using this product

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

STOP USE

Stop using this product if

• condition persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

DOSAGE & ADMINISTRATION

Directions

• clean effected area
• apply small amount of this product on the area 1-3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first

SPL UNCLASSIFIED SECTION

Other information

• store at room temperature
• does not contain, nor is intended as a substitute for grain or ethyl alcohol
• will produce serious gastric disturbances if taken internally

INACTIVE INGREDIENT

Inactive Ingredients

Water(Aqua), Methyl Salicylate, FD&C Blue #1, FD&C Yellow #5

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
FIRST AID ANTISEPTIC
12 FL.OZ (355 mL)

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	50 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-051-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020
2	NDC: 52000-051-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020
3	NDC: 52000-051-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020
4	NDC: 52000-051-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020
5	NDC: 52000-051-05	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020
6	NDC: 52000-051-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020
7	NDC: 52000-051-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52000-051)