Isopropyl Rubbing Alcohol 50% With Wintergreen And Glycerin (Isopropyl Alcohol) Liquid [North & South Wholesalers Llc] -

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN AND GLYCERIN (ISOPROPYL ALCOHOL) LIQUID [NORTH & SOUTH WHOLESALERS LLC]
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NDC	70201-002-01, 70201-002-02, 70201-002-03, 70201-002-04, 70201-002-05, 70201-002-06, 70201-002-07
Set ID	f15f4921-9cf5-4a8e-91ea-6090bfcf146a
Category	HUMAN OTC DRUG LABEL
Packager	North & South Wholesalers LLC
Generic Name
Product Class
Product Number
Application Number	PART333A

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ACTIVE INGREDIENT

Active Ingredients (by volume)

Isopropyl alcohol (50% conc.)
PURPOSE

Purpose

First aid antiseptic
INDICATIONS & USAGE
Uses
- first aid to help prevent the risk of infection in minor cuts, scrapes and burns
WARNINGS

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical
ASK DOCTOR
Ask a doctor before use if you have
- deep punctured wounds, animal bites or serious burns
WHEN USING
When using this product
- do not get into eyes
- do not apply over large areas of the body
- do not use longer than one week unless directed by a doctor
STOP USE
Stop using this product if
- condition persists or gets worse
KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately
DOSAGE & ADMINISTRATION
Directions
- clean effected area
- apply small amount of this product on the area 1-3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
SPL UNCLASSIFIED SECTION
Other information
- store at room temperature
- does not contain, nor is intended as a substitute for grain or ethyl alcohol, will produce serious gastric disturbance if taken internally
INACTIVE INGREDIENT

Inactive Ingredients

water (aqua), methyl salicylate, FD&C Blue #1, FD&C Yellow #5, & Glycerin
PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN AND GLYCERIN

FIRST AID ANTISEPTIC

12 FL.OZ (355 mL)

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN AND GLYCERIN
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70201-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	50 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description
Packaging
1	NDC:70201-002-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:70201-002-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:70201-002-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:70201-002-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC:70201-002-05	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC:70201-002-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC:70201-002-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/03/2015

Labeler - North & South Wholesalers LLC (004948495)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(70201-002)

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Medic

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN AND GLYCERIN (ISOPROPYL ALCOHOL) LIQUID [NORTH & SOUTH WHOLESALERS LLC]

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