Orajel SEVERE PM Toothache & Gum Relief Plus TRIPLE MEDICATED

Orajel Instant Pain Relief by

Drug Labeling and Warnings

Orajel Instant Pain Relief by is a Otc medication manufactured, distributed, or labeled by Church Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAJEL INSTANT PAIN RELIEF SEVERE PM- benzocaine 20%, menthol, benzalkonium chloride 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 Plus

TRIPLE MEDICATED

Active ingredients

Benzocaine 20%

Menthol 0.25%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Oral Pain reliever

Antiseptic

Use

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

Warnings

Allergy alert: do not use this product if you have a histoy 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

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 samll amount of product to the cavity and around gum surrounding the teeth. 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 physicaian or healthcare provider

Other information

  • do not use if tube tip is cut prior to opening
  • this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • Orajel Severe Pain Formula will stay in place for extended duration of relief
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

Principal Display - OJFC-31854-06



#1 Oral Pain Reliever

for Toothache



Orajel Instant Pain Relief



SEVERE PM

Toothache & Gum Relief Plus



TRIPLE MEDICATED

Nigthtime Formula with Chamomile



20% Benzocaine to Relieve Oral Pain

Antiseptic to Help Prevent Infection

Menthol to Soothe



ORAL PAIN RELIEVER/ANTISEPTIC NET WT 0.25 OZ (7.0g) LONG-LASTING CREAM

Carton image

ORAJEL INSTANT PAIN RELIEF  SEVERE PM
benzocaine 20%, menthol, benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10237-748
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CHAMOMILE (UNII: FGL3685T2X)  
GELATIN (UNII: 2G86QN327L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-748-251 in 1 CARTON12/01/201312/20/2019
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 finalpart35612/01/201312/20/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church Dwight Co., Inc.043690812manufacture(10237-748)

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