Orajel Antiseptic Mouth Sore Rinse

Orajel Antiseptic Rinse for Mouth Sores by

Drug Labeling and Warnings

Orajel Antiseptic Rinse for Mouth Sores by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL ANTISEPTIC RINSE FOR MOUTH SORES- hydrogen peroxide liquid 
Church & Dwight Co., Inc.

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.

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Orajel Antiseptic Mouth Sore Rinse

Active ingredient

Active ingredient

hydrogen peroxide 1.5%

Purpose

Oral debriding agent

Uses

for temporary use in cleansing minor wounds or minor gum inflammation resulting from:

  • minor dental procedures
  • orthodontic appliances
  • dentures
  • accidental injury
  • canker sores
  • other irritations of the mouth and gums

Aids in the removal of:

  • phlegm
  • mucus
  • other secretions associated with occasional sore mouth

Warnings

Do not use this product for more than 7 days unless directed by a dentist or doctor

When using this product do not swallow

Stop use

Stop use and see your dentist or doctor promptly if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

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

Directions

  • remove imprinted safety seal from bottle cap
  • to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

Adults and children 2 years of age and older

  • Swish one-half capful (2 teaspoons = 10 mL) 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 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

  • cap tightly
  • keep away from heat or direct sunlight
  • do not use if safety seal is broken or missing

Inactive ingredients

alcohol (4.1% by volume), blue 1, disodium EDTA, methylparaben, methyl salicylate, phosphoric acid, poloxamer 338, purified water, sodium saccharin, sorbitol

Questions or comments?

call us at 1-800-952-5080 M-F 9am - 5pm ETor visit our website at www.orajel.com

PROMOTES HEALING of

CANKER SORES, GUM IRRITATION,

CHEEK BITES and DENTURE IRRITATION

mint

NEW LOOK!

Orajel

Antiseptic Rinse

FOR ALL MOUTH SORES

PROMOTES HEALING

KILLS BACTERIA

ORAL DEBRIDING AGENT

HYDROGEN PEROXIDE 1.5%

16 FL OZ (473.2 mL)

32499

ORAJEL ANTISEPTIC RINSE FOR MOUTH SORES 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10237-720
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.015 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-720-16473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/201012/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/201012/18/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663manufacture(10237-720)

Revised: 12/2019
 
Church & Dwight Co., Inc.