BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel severe pm toothache and gum relief cream 
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 Severe PM Toothache & Gum Relief

Benzocaine 20%

Menthol 0.25%

Zinc Chloride 0.15%

Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

Warnings

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider

Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Directions • cut open tip of tube on score mark

Adults and children 2 years of age and over - Apply a small amount of product to the affected area, use up to 4 times daily or as directed by a physician or healthcare provider

Children under 12 years of age - Should be supervised in the use of this product

Children under 2 years of age - Ask a physician or healthcare provider

Other Information • do not use if tube tip is cut prior to opening • do not use continuously • Cream will stay in place for extended duration of relief.

cellulose gum, chamomile, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

Question or comments call us at 800 952 5080 Monday through Friday 9-5 or visit www orajel com

Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

#1

Oral Pain

Reliever Brand

For Toothache

New Formula!

3x More

Acitve Ingredients*

Orajel

Instant Pain Relief

Severe PM

Toothache & Gum Relief Plus

Triple Medicated

Nighttime Formula with Chamomile

20% Benzocaine to Relieve Oral Pain

Astringent to Relieve Gum Irritation NEW

Menthol to Soothe Gums

Oral Pain Reliever/Astringent NET WT 0.25 OZ. (7.0 g)

Long-Lasting

Cream

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OJFC-31854-10 (2).jpg

BENZOCAINE, MENTHOL, ZINC CHLORIDE 
orajel severe pm toothache and gum relief cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-771
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CHAMOMILE (UNII: FGL3685T2X)  
GELATIN (UNII: 2G86QN327L)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-771-251 in 1 CARTON04/27/201712/17/2021
17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/27/201712/17/2021
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-771)

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