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 FOUR SEASONS TRADING INC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (by volume)

Isopropyl alcohol (50% concentrate)

PURPOSE

Purpose

topical antimicrobial

INDICATIONS & USAGE

Uses

• to decrease germs in minor cuts and scrapes
• helps relieve minor muscular aches due to exertion

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.

WHEN USING

When using this product

• do not get into eyes or mucous membranes
• use only in a well-ventilated area

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 of 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 Ingredients

Water, Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69274-002
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: 69274-002-01	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 69274-002-02	177 mL in 1 BOTTLE, PLASTIC
3	NDC: 69274-002-03	237 mL in 1 BOTTLE, PLASTIC
4	NDC: 69274-002-04	296 mL in 1 BOTTLE, PLASTIC
5	NDC: 69274-002-05	354 mL in 1 BOTTLE, PLASTIC
6	NDC: 69274-002-06	414 mL in 1 BOTTLE, PLASTIC
7	NDC: 69274-002-07	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/25/2014

Labeler - FOUR SEASONS TRADING INC (169331464)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(69274-002)