Label: HYDROGEN PEROXIDE FIRST AID ANTISEPTIC- hydrogen peroxide liquid
- NDC Code(s): 53329-981-06, 53329-981-25
- Packager: Medline Industries, Inc.
- 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 June 6, 2016
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- Active ingredient
Hydrogen peroxide (stabilized) 3%Close
First Aid AntisepticClose
Oral debriding agent
- 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
- 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.
First aid antiseptic:
- Clean the affected area
- Apply a small amount of product on the area 1 to 3 times daily
- 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, 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. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.Close
- Inactive ingredients
- Principal Display Panel - Packet
First aid antiseptic
Oral debriding agent
For your protection
16 FL OZ
(1 PT) 473 mLClose
- INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE FIRST AID ANTISEPTIC
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-981 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:53329-981-06 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2007 2 NDC:53329-981-25 3780 mL in 1 JUG; Type 0: Not a Combination Product 01/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2007 Labeler - Medline Industries, Inc. (025460908)