OTC Medication Information: HYDROGEN PEROXIDE

HYDROGEN PEROXIDE- hydrogen peroxide liquid
DEGASA SA DE CV

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.

Active Ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First Aid Antiseptic Oral debriding agent

Inactive Ingredients:

Purified water

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 ocassional 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.

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.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

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 o 3 times a day

√ May be covered with a sterile bandage.

√ If bandaged, let dry first.

Oral debriding agent:

Adults, children over 2 years of age:

√ 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.

√ Children under 12 years of age should be supervised in the use.

√ Children under 2 years of age: consult a dentist, doctor.

Other Information

√ Keep tightly closed and at controlled room temperature.

√ Do not shake bottle.

√ Hold away form face when opening.

Question or comments?

Call 956 728-8899

Package Labeling:

HYDROGEN PEROXIDE hydrogen peroxide liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67326-354 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE 0.3 mL in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67326-354-01 946 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/15/2020

Labeler — DEGASA SA DE CV (812771980)

Establishment
Name	Address	ID/FEI	Operations
DEGASA SA DE CV		812771980	manufacture (67326-354)

Revised: 03/2020 DEGASA SA DE CV