Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

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HYDROGEN PEROXIDE- hydrogen peroxide solution 
FOODHOLD U.S.A., 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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Hydrogen Peroxide

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First Aid Antiseptic

Oral debriding agent

Use

• first aid to help prevent the risk of infection in minor cuts, scrapes and burns
• aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use  only

Do not use

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

Ask a doctor before use if you have

deep or pucture wounds, animal bites or serious burns

Stop Use and ask a doctor if

• the condition persists or gets worse
• sore mouth symptoms do not improve in 7 days
• 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.

Directions

First Aid Antiseptic:

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

Oral Debriding Agent: 

• adults, children over 2 years of age
• mix with equal amount of water
• swish around in the mouth over the affected area for at least 1 minute, then spit out
• use up to 4 times daily after meals and at bedtime
• children under 12 years of age should be supervised in the use
• children under 2 years of age: consult a dentist or doctor

Other information

Keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

purified water

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

Quality Guaranteed or your money back

principal display panel

Do not use if printed seal under cap is broken or missing

CAREONE

Hydrogen Peroxide

TOPICAL SOLUTION USP

First Aid Antiseptic

Oral Debriding Agent

HYDROGEN PEROXIDE 3%

FOR TREATMENT OF MINOR CUTS AND ABRASIONS

FOR USE AS A GARGLE OR RINSE

OUR PHARMACIST RECOMMEND

16 FL OZ (473 mL)

871.001/871AA

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-942
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	30 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-942-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/10/2011
2	NDC: 41520-942-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/10/2011
3	NDC: 41520-942-50	710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/10/2011
4	NDC: 41520-942-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/10/2011
5	NDC: 41520-942-99	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/10/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/10/2011

Labeler - FOODHOLD U.S.A., LLC (809183973)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41520-942)

Revised: 12/2018

Document Id: 1d4fd086-ae7c-474e-91d7-ef035324c2de

34390-5

Set id: 1d9bacfd-2739-4948-98e3-d90323db9c7a

Version: 5

Effective Time: 20181226

 

FOODHOLD U.S.A., LLC