Label: ORAL SORE ANTISEPTIC- hydrogen peroxide, menthol liquid
- NDC Code(s): 72476-024-43
- Packager: Retail Business Services, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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Uses
▪ first aid to help protect against bacterial contamination in minor oral wounds
▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or
minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures
▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth
and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with
occasional sore mouth - Warnings
- Stop use and ask a doctor if
- When using this product
- Keep out of reach of children
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Directions
Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician
Children under 12 years of age - should be supervised in the use of the product
Children under 2 years of age - consult a dentist or doctor
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY ADUSA DISTRIBUTION, LLC
SALISBURY, NC 28147
For product questions or concerns,
contact us at 1-833-992-3872
Quality guarenteed or your money back.
*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse Mouth Sores.
DSP-TN-21091 DSP-MO-20087
- Principal display panel
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INGREDIENTS AND APPEARANCE
ORAL SORE ANTISEPTIC
hydrogen peroxide, menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYL SALICYLATE (UNII: LAV5U5022Y) PHOSPHORIC ACID (UNII: E4GA8884NN) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-024-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/13/2023 Labeler - Retail Business Services, LLC (967989935) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(72476-024)