Orajel Dry Mouth Moisturizing Gel

Orajel Dry Mouth Moistruizing by

Drug Labeling and Warnings

Orajel Dry Mouth Moistruizing by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL DRY MOUTH MOISTRUIZING- glycerin gel 
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 Dry Mouth Moisturizing Gel

Active ingredient               Purpose

Glyercin 18%                           Oral demulcent

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 of age and older

• Apply a one-inch strip of product directly to tongue and around 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

Purpose: Oral demulcent

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.

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

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

Warnings

Keep out of 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.

CONTAINS A PATENTED

ANTIOXIDANT FORMULA

SUGAR FREE

PLEASANT TASTING

LONG-LASTING

DRY MOUTH RELIEF

• MOISTENS ON CONTACT
• REDUCES GUM IRRITATION
• SOOTHES AND PROTECTS DRY MOUTH TISSUES
• PROMOTES ORAL HEALING

Orajel DRY MOUTH MOISTURIZING GEL

RELIEVES DRY MOUTH SYMPTOMS CAUSED BY:

• DIABETES
• MEDICATIONS
• STRESS AND DEPRESSION
• DRUG/RADIATION THERAPIES
• SJOGRENS SYNDROME
• VITAMIN DEFICIENCIES

Orajel

GLYCERIN 18%

DRY MOUTH

MOISTURIZING GEL

ORAL DEMULCENT

NET WT 1.5 oz (42 g)

ORAJEL DRY MOUTH MOISTRUIZING 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-719
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	180 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-719-15	1 in 1 CARTON	07/21/2010	08/24/2019
1		42 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	07/21/2010	08/24/2019

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-719)

Revised: 12/2019

Document Id: 9b04afec-1637-1e14-e053-2995a90a8b2b

34390-5

Set id: 0d371e48-d722-4b77-b354-5a44179247bc

Version: 10

Effective Time: 20191231

 

Church & Dwight Co., Inc.