Label: PERIOGEL- hydrogen peroxide gel
- NDC Code(s): 75908-017-28, 75908-017-85
- Packager: QNT Anderson, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Hydrogen peroxide 1.7% (w/w)Close
Oral Debriding Agent/Oral Wound CleanserClose
- Approved Uses
For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.Close
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens;
- swelling, rash or fever develops.
- Directions for adults and children 2 years of age and older
- Apply several drops to the affected area of the mouth.
- Allow medication to remain in place at least 1 minute and then spit out.
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
- Children under 12 years of age should be supervised in the use of this product.
- Children under 2 years of age:
Consult a dentist or doctor.
- Other information
Store at controlled room temperature (68°-77°F) in a cool, dry place away from direct sunlight.Close
- Inactive ingredients
Inactive ingredients: ethyl alcohol (5% w/w), menthol, methyl salicylate, phosphoric acid, poloxamer 407, polysorbate 20, potassium sorbate, sodium saccharin, sorbitol, water.Close
- Questions or comments?
Call toll free 1-877-907-3746 from 9am - 5pm CST/CDT Monday-Friday.Close
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
Oral Debriding Agent /
Oral Wound Cleanser
NET WT. 3 OZ. (85 g)
- INGREDIENTS AND APPEARANCE
hydrogen peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75908-017 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V) hydrogen peroxide 17 mg in 1 g Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) 50 mg in 1 g menthol (UNII: L7T10EIP3A) methyl salicylate (UNII: LAV5U5022Y) phosphoric acid (UNII: E4GA8884NN) poloxamer 407 (UNII: TUF2IVW3M2) polysorbate 20 (UNII: 7T1F30V5YH) potassium sorbate (UNII: 1VPU26JZZ4) saccharin sodium (UNII: SB8ZUX40TY) sorbitol (UNII: 506T60A25R) water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75908-017-85 1 in 1 CARTON 1 85 g in 1 TUBE 2 NDC:75908-017-28 1 in 1 CARTON 2 28.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/01/2011 Labeler - QNT Anderson, LLC (962173030) Establishment Name Address ID/FEI Business Operations Unicep Packaging, Inc. 790263909 MANUFACTURE