LEADER 70% ISOPROPYL Alcohol Wipes

Drug Labeling and Warnings

Drug Details [pdf]

LEADER ISOPROPYL ALCOHOL WIPES- isopropyl alcohol liquid 
Cardinal Health

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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LEADER 70% ISOPROPYL Alcohol Wipes

LEADER 70% ISOPROPYL Alcohol Wipes

Active ingredient

Isopropyl Alcohol 70%

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in:

• minor cuts
• scrapes
• 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 or puncture wounds, animal bites or serious burns
  

When using this product

• do not get in eyes
• do not apply over large areas
• do not use longer than 1 week unless directed by a doctor
  

Stop use and ask a doctor if

condition persists or gets worse

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the affected area
• apply product on the affected area of the body 1 to 3 times a day
• may be covered with a sterile bandage
• if bandaged, let dry first
  

Other information

Do not apply internally. Keep canister tightly closed and at controlled room temperature. Hold away from face when opening.

Inactive ingredient

purified water

LEADER 70% ISOPROPYL Alcohol Wipes 40 count (49781-109-40)

LEADER ISOPROPYL ALCOHOL WIPES 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-109
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-109-40	40 in 1 CANISTER	04/10/2014	09/15/2019
1		4.5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/10/2014	09/15/2019

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Kleen Test Products Corporation		168165814	manufacture(49781-109)

Revised: 10/2019

Document Id: 950ba5cd-93b9-d0cd-e053-2a95a90a1560

34390-5

Set id: 7170ad3b-9bd5-4e1b-8e8e-443a680b81b5

Version: 2

Effective Time: 20191016