Label: MAXIM HYDROGEN PEROXIDE- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69950-005-01 - Packager: Ostl, 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.
Drug Label Information
Updated October 6, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (by volume)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
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
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DOSAGE & ADMINISTRATION
Directions
first aid antiseptic:
- 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
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 atleast 1 minute and then spit out
- use upto 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
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
MAXIM HYDROGEN PEROXIDE
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69950-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Hydrogen Peroxide 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PHOSPHORIC ACID (UNII: E4GA8884NN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69950-005-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/2015 Labeler - Ostl, Inc. (020117798) Establishment Name Address ID/FEI Business Operations WILSON MEDICINE COMPANY 916000287 manufacture(69950-005)
