ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

Isopropyl Rubbing Alcohol by

Drug Labeling and Warnings

Isopropyl Rubbing Alcohol by is a Otc medication manufactured, distributed, or labeled by Pioneer Associates, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (by volume)

Isopropyl alcohol (50% conc.)

PURPOSE

Purpose

first aid antiseptic

INDICATIONS & USAGE

Uses

• first aid to help prevent risk of infection in:
• minor cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only

• flammable, keep away from fire and flame
• will produce serious gastric disturbances if taken internally

ASK DOCTOR

Ask a doctor before use if you have deep puncture wounds or serious burns

DO NOT USE

When using this product

• do not get into eyes or mucous membranes
• use in well-ventilated area: forms may be toxic

STOP USE

Stop use and ask a doctor if condition persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of an accidental ingestion, contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions

• apply to skin directly or with clean gauze, cotton or swab
• for rubbing apply liberally and rub with hands

SPL UNCLASSIFIED SECTION

Other information

• does not contain, nor is intended as a substitute for grain or ethyl alcohol
• keep bottle tightly closed

INACTIVE INGREDIENT

Inactive ingredient

Water (Aqua)

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

CAVALIER ISOPROPYL RUBBING ALCOHOL 50%

FIRST AID ANTISEPTIC

12 FL.OZ (354 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53033-001
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53033-001-01	119 mL in 1 BOTTLE, PLASTIC
2	NDC: 53033-001-02	178 mL in 1 BOTTLE, PLASTIC
3	NDC: 53033-001-03	237 mL in 1 BOTTLE, PLASTIC
4	NDC: 53033-001-04	295 mL in 1 BOTTLE, PLASTIC
5	NDC: 53033-001-05	354 mL in 1 BOTTLE, PLASTIC
6	NDC: 53033-001-06	414 mL in 1 BOTTLE, PLASTIC
7	NDC: 53033-001-07	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	08/24/2012

Labeler - Pioneer Associates (012604336)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(53033-001)