NXN - HYDROGEN PEROXIDE - 3% TOPICAL SOLUTION USP (77761-103) - DELISTED

NXN HYDROGEN PEROXIDE by

Drug Labeling and Warnings

NXN HYDROGEN PEROXIDE by is a Otc medication manufactured, distributed, or labeled by NXN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NXN HYDROGEN PEROXIDE- hydrogen peroxide solution 
NXN BEAUTY, 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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NXN - HYDROGEN PEROXIDE - 3% TOPICAL SOLUTION USP (77761-103) - DELISTED

ACTIVE INGREDIENT

HYDROGEN PEROXIDE 3%

PURPOSE

ANTISEPTIC

USES

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 puncture wounds, animal bites or serious burns.

Stop use and ask a doctor before 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 product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first

Oral debridlng agent

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

OTHER INFORMATION

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

INACTIVE INGREDIENTS

purified water

QUESTIONS?

(310) 469-9150

NXN HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77761-103
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 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77761-103-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/06/2021	12/31/2021

Labeler - NXN BEAUTY, LLC (029125799)

Revised: 4/2022

Document Id: dc91aa6c-75b4-41a5-e053-2995a90a082b

34390-5

Set id: e823ad41-5cc3-4425-a592-f897344e3c53

Version: 4

Effective Time: 20220413