50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid

50% Isopropyl Rubbing Alcohol with Wintergreen by

Drug Labeling and Warnings

50% Isopropyl Rubbing Alcohol with Wintergreen by is a Otc medication manufactured, distributed, or labeled by AMERICAN CONSUMER PRODUCTS LLC, 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

Topical Antimicrobial

INDICATIONS & USAGE

Uses

• 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 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 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 Ingredients

Water (Aqua), Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGEEN

Topical Antimicrobial

12 FL.OZ (354 mL)

INGREDIENTS AND APPEARANCE

50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 18027-003
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: 18027-003-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017
2	NDC: 18027-003-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017
3	NDC: 18027-003-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017
4	NDC: 18027-003-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017
5	NDC: 18027-003-05	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017
6	NDC: 18027-003-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017
7	NDC: 18027-003-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2017

Labeler - AMERICAN CONSUMER PRODUCTS LLC (858427334)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(18027-003)