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:

Label

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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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