PREVENT HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide spray 
Eco-Med Pharmaceuticals, Inc.

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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Prevent+ Hydrogen Peroxide 3% USP Spray

DRUG FACTS

ACTIVE INGREDIENT

Hydrogen Peroxide 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. 

When using this product:

Do not get into eyes. Do not apply over large areas of the body. Do not use longer than one week unless directed by a doctor .

STOP USE AND ASK A DOCTOR IF:

Condition persists or gets worse.

If 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.

In case of ingestion, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

For first aid antiseptic use: Clean affected area, apply small amount of product on affected area 1-3 times a day. May be covered with a sterile bandage, If bandaged, let dry first, For 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 affected area for at least 1 minute and then spit out. Do not swallow. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. Children under 12 years 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 and in a dark place at room temperature. Do not shake bottle. Hold away from face when opening.

INACTIVE INGREDIENT:

Purified water.

Questions:

1-844-432-6633 Mon- Fri 8am - 4 pm (EST) Email: info@eco-med.com

Package Labeling:

Label3Box3

PREVENT HYDROGEN PEROXIDE 3 PERCENT 
hydrogen peroxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78835-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.03 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78835-007-0124 in 1 BOX10/15/2020
1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/15/2020
Labeler - Eco-Med Pharmaceuticals, Inc. (249183435)

Revised: 10/2020
Document Id: b2d52970-0bd0-1dbe-e053-2a95a90a1475
Set id: b2d4d3b1-c653-5bf6-e053-2a95a90a099a
Version: 1
Effective Time: 20201029
 
Eco-Med Pharmaceuticals, Inc.