ALLURE ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid
Universal Distribution Center LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ALLURE ISOPROPYL RUBBING ALCOHOL

Active Ingredients

Isopropyl alcohol (50% conc.)

Purpose

First aid antiseptic

Uses

First aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

For external use only

flammable, keep away from fire or flame, heat, spark, electrical

Ask a doctor before use if you have

deep puncture wounds, animal bites or serious burns

When using this product

do not get into eyes
do not apply over large areas of body
do not use longer than one week unless directed by a doctor

Stop using this product if

condition persists or gets worse

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

Directions

clean affected area
apply a small amount of this product on the area 1-3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Inactive ingredient

purified water

Packaging

untitled

ALLURE ISOPROPYL RUBBING ALCOHOL
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52000-001
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52000-001-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
2	NDC:52000-001-02	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
3	NDC:52000-001-03	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
4	NDC:52000-001-04	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
5	NDC:52000-001-05	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
6	NDC:52000-001-06	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012
7	NDC:52000-001-07	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/29/2012

Labeler - Universal Distribution Center LLC (019180459)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-001)

Name	Address	ID/FEI	Business Operations
Establishment
NOWREZ & ISMAIL SHUKRI COMPANY		534665497	manufacture(52000-001)