LEADER 3% USP Hydrogen Peroxide Wipes

Drug Labeling and Warnings

Drug Details [pdf]

LEADER HYDROGEN PEROXIDE WIPES- hydrogen peroxide 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 3% USP Hydrogen Peroxide Wipes

LEADER 3% USP Hydrogen Peroxide Wipes

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in:

• minor cuts
• scrapes
• burns
  

Warnings

For external use only

Ask a doctor before use if you have

• deep or puncture wounds, animal bites or serious burns
  

Do not use

• in eyes or apply over large areas of the body
• longer than 1 week

Stop use and ask a doctor if

• condition persists or gets worse
• irritation, pain, or redness persists or worsens
• swelling, rash or fever develops
  

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.
• Do not get in eyes.

Directions

• First Aid Antiseptic
• 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

Keep canister tightly closed and at controlled room temperature. Hold away from face when opening.

Inactive ingredient

purified water

LEADER 3% USP Hydrogen Peroxide Wipes 40 count (49781-108-40)

LEADER HYDROGEN PEROXIDE WIPES 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 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: 49781-108-40	40 in 1 CANISTER	04/10/2014	09/15/2019
1		6 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(49781-108)

Revised: 10/2019

Document Id: 950bb1dc-e162-700b-e053-2995a90aaef1

34390-5

Set id: 194117a8-15d7-4700-9694-4be33244abd1

Version: 2

Effective Time: 20191016