HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by DealMed Medical Supplies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 removal of phlegm, mucous, 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 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 (1-800-222-1222).

Directions

• First Aid Antiseptic clean the affected area apply a small amount of product on the 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 & 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 of this 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 Ingredient

Purified Water

Principal Display Panel 16 oz

REF: 781090

NDC: 70082-111-16

DEALMED

Hydrogen

Peroxide

3% USP

Tamper evident cap for your protection. If ring band is detatche or missing do not use.

16 fl. oz. *473 mL)

Aqua Oxigenada 3% USP

made in the usa for

Dealmed Medical

3512 quentin road

Brooklyn, NY 11234

www.dealmed.com

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70082-111
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: 70082-111-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	07/18/2018

Labeler - DealMed Medical Supplies LLC (068586441)