ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL- isopropyl alcohol liquid

Isopropyl Rubbing Alcohol with Wintergreen Oil by

Drug Labeling and Warnings

Isopropyl Rubbing Alcohol with Wintergreen Oil 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), methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

CAVALIER ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN OIL

FIRST AID ANTISEPTIC

12 FL.OZ (354 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53033-002
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)
PEG-75 LANOLIN (UNII: 09179OX7TB)
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: 53033-002-01	119 mL in 1 BOTTLE, PLASTIC
2	NDC: 53033-002-02	178 mL in 1 BOTTLE, PLASTIC
3	NDC: 53033-002-03	237 mL in 1 BOTTLE, PLASTIC
4	NDC: 53033-002-04	295 mL in 1 BOTTLE, PLASTIC
5	NDC: 53033-002-05	354 mL in 1 BOTTLE, PLASTIC
6	NDC: 53033-002-06	414 mL in 1 BOTTLE, PLASTIC
7	NDC: 53033-002-07	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(53033-002)