Orajel Dry Mouth Moistruizing

Dosage form: gel
Ingredients: GLYCERIN 180mg in 1g
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-719

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 FACTs


Active ingredient               Purpose

Glyercin 18%                           Oral demulcent

Use for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

Keep out of the reach of children. If an excessive amount of gel is accidentally swallowed, get medical help or contact a Poison Control Center right away.  If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.  If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Directions   use as needed or as directed by a dentist or doctor
                      puncture safety seal with opposite end of tube cap
                      do not use if safety seal is damaged or mission prior to first use

Adults and children 2 years            Apply a one-inch strip of product directly to tongue and around of age and older                            the inside and outside of the tooth and gum surface.  Do not                                                        rinse out.

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



Inactive ingredients  calcium disodium EDTA, citric acid, disodium phosphate, flavor, methylparaben, propylparaben, purified water, sorbitol, sucralose, Thinone Complex (a patented proprietarey blend of antioxidants, xanthan gum.

Questions or comments:  Call us at 1-800952-5080 M-F 9am-5pm ET or visit our webiste at www.orajel.com

Carton image

ORAJEL DRY MOUTH MOISTRUIZING 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-719
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN180 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE CALCIUM DISODIUM ANHYDROUS 
CITRIC ACID MONOHYDRATE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:10237-719-151 TUBE (TUBE) in 1 CARTON
142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/21/2010
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812manufacture

Revised: 07/2010
 
Church & Dwight Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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