ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid

Isopropyl Rubbing Alcohol With Wintergreen by

Drug Labeling and Warnings

Isopropyl Rubbing Alcohol With Wintergreen by is a Otc medication manufactured, distributed, or labeled by Home Smart Products, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (by volume)

Isopropyl alcohol (70% 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

DO NOT USE

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 ingredient

Water, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREEN
TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 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: 52862-009-03	119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012
2	NDC: 52862-009-04	178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012
3	NDC: 52862-009-06	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012
4	NDC: 52862-009-09	295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012
5	NDC: 52862-009-10	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012
6	NDC: 52862-009-11	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012
7	NDC: 52862-009-12	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/22/2012

Labeler - Home Smart Products (161872676)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52862-009)