Label: PERIOGEL- hydrogen peroxide gel
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Contains inactivated NDC Code(s)
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
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 May 13, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Approved Uses
- Warnings
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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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
PERIOGEL
hydrogen peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75908-017 Route of Administration DENTAL 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, unspecified form (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 04/01/2011 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:75908-017-28 1 in 1 CARTON 04/01/2011 2 28.3 g in 1 TUBE; Type 0: Not a Combination Product 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(75908-017)