Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid
- NDC Code(s): 70000-0500-1, 70000-0500-2
- Packager: Cardinal Health (Leader) 70000
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated April 5, 2019
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- Active ingredient
Hydrogen peroxide 3%Close
First aid antiseptic/oral debriding agentClose
- 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
For external use only.
Stop use and ask a doctor if
- swelling, rash, or fever develops
- the condition persists or gets worse
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
For use as a first aid antiseptic:
- clean affected area
- if bandaged, let dry first
- apply small amount if product on affected area 1-3 times a day
- may be covered with a sterile bandage
For use as an 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 it 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 doctor or dentist
- 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
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
- Package Label
LEADER Hydrogen Peroxide 3% USP
- INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE 3 PERCENT
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0500 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:70000-0500-1 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2019 2 NDC:70000-0500-2 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 02/28/2019 Labeler - Cardinal Health (Leader) 70000 (097537435)