ORAJEL MAXIMUM STRENGTH- benzocaine and menthol 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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Drug Facts

Active Ingredients

Benzocaine 20%

Menthol 0.25%

Oral pain reliever

Use for temporary relief of pain due to toothaches

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 dentist or doctor

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

Keep out of reach of children.

In case of overdose, 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 cavity and around gum surrounding the teeth. Use up to 4 times daily 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

Ask a dentist or doctor

Other information • do not use if tube tip is cut prior to opening • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted • do not use continously • Orajel PM will stay in place for extended duration of relief

Inactive Ingredients cellulose gum, chamomile, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyehylene glycol, sodium saccharin

Questions or comments call us at 800 952 5080 Monday through Friday 9 am to 5 pm or visit our website at www orajel com

#1 Oral Pain Reliver

For Toothache

Cream

Now with Chamomile!

Orajel PM

Instant Pain Relief

For Severe Toothache

Maxiumum Strength

Long Lasting Formula

for Nightime

31854

ORAJEL  MAXIMUM STRENGTH
benzocaine and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-706
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
GELATIN (UNII: 2G86QN327L)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PECTIN (UNII: 89NA02M4RX)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-706-251 in 1 CARTON
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 finalpart35605/10/201003/07/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-706)

Revised: 3/2016
 
Church & Dwight Co., Inc.