NDC 62864-760 Orajel Antiseptic Rinse For All Mouth Sores

NDC Product Code 62864-760

NDC 62864-760-16

Package Description: 473.2 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Orajel Antiseptic Rinse For All Mouth Sores with NDC 62864-760 is a product labeled by Church & Dwight Canada Corp.. The generic name of Orajel Antiseptic Rinse For All Mouth Sores is . The product's dosage form is and is administered via form.

Labeler Name: Church & Dwight Canada Corp.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • 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)
  • ALCOHOL (UNII: 3K9958V90M)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Church & Dwight Canada Corp.
Labeler Code: 62864
Start Marketing Date: 11-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Orajel Antiseptic Rinse For All Mouth Sores Product Label Images

Orajel Antiseptic Rinse For All Mouth Sores Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredient Hydrogen peroxide 1.5%Menthol 0.1%

Otc - Purpose

PurposeOral debriding agent/Oral antisepticOral pain reliever

Indications & Usage

  • Usesfirst aid to help reduce bacteria in minor oral woundsfor temporary pain relief anduse in cleansing minor wounds or minor gum inflammation resulting from:minor dental proceduresaccidental injuryorthodontic appliancescanker soresdenturesother irritations of the mouth and gumsAids in the removal ofphlegmmucusother secretions associated with occasional sore mouth

Warnings

  • WarningsDo not use this product for more than 7 days unless directed by a dentist or healthcare provider
  • When using this product do not swallowdo not exceed recommended dosage

Otc - Stop Use

  • Stop Use and see your physician promptly ifswelling, rash or fever developsirritations, pain or redness persists or worsenssore mouth symptoms do not improve in 7 days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away

Dosage & Administration

  • Directionsremove imprinted safety seal from bottle capto remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.Adults and children2 years of age and olderSwish one-half capful (2 tesapoons=10mL) around the mouth over the affected area for 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 healthcare providerChildren under 12 years of ageShould be supervised in the use of this productChildren under 2 years of ageConsult a dentist or healthcare provider

Other Safety Information

  • Other Informationcap tightlykeep away from heat or direct sunlightdo not use if safety seal is broken or missing

Inactive Ingredient

Inactive ingredients alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

Otc - Questions

Questions or comments call us at






1–800–952–5080 M–F 9am–5pm ET or visit our website atwww.orajel.com

Orajel Alcohol Free Antiseptic Rinse

#1PAIN RELIEVERBRAND FOR ADULTSNOW WITH PAIN RELIEF!OrajelAntiseptic RinseFOR ALL MOUTH SORESCanker Sores Cheek Bites Gum IrritationIrritatrion from Dentures or BracesPromotes HealingKills BacteriaProvides Pain ReliefFRESH MINTORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER16 FL OZ (473.2 mL)Front Label OJLBF-32499-04.jpg



Back Label OJLBB-32499-04.jpg

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