HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Nice-Pak Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First Aid Antiseptic

Oral debriding agent

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 one week

Ask a doctor before use if you have

deep or puncture 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 product on the affected area 1 to 3 times a day
• may be covered with a sterile bandage
• if bandaged, let dry first

Oral debriding agent (oral rinse): 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 then 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
• 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

Adverse reaction

Distributed by: Consumer Product Partners, LLC.

St. Louis, MO 63114

1-888-593-0593

Pat. D675, 101

Principal Display Panel

Swan ®

Hydrogen

Peroxide

Topical Solution USP

• First Aid Antiseptic/Oral Debriding Agent
• For treatment of minor cuts & abrasions
• For use as a gargle or rinse

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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

32 FL OZ (1 QT) 946 mL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-871
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: 11344-871-72	295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/09/2017
2	NDC: 11344-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2017
3	NDC: 11344-871-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2017
4	NDC: 11344-871-99	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/09/2017
5	NDC: 11344-871-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2017
6	NDC: 11344-871-82	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/09/2017

Labeler - Nice-Pak Products, LLC (119091520)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(11344-871)