BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel instant pain relief severe 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 Instant Pain Relief Severe Toothache & Gum

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

Benzocaine - Oral pain reliever

Menthol - Oral pain reliever

Zinc Chloride - Oral astringent

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, 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 older - 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 • Gel will stay in place for extended duration of relief

blue 1, cellulose gum. gelatin, methyl saliclate, mineral oil, pectin, petrolatum, polyethylen glycol, sodium saccharin

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

#1

Oral Pain

Reliver Brand

For Toothache

New Formula!

3X More

Active Ingredients*

Orajel™

Instant Pain Relief

Severe

Toothache & Gum Relief Plus

Triple Medicated

20% Benzocaine to Relieve Oral Pain

Astringent to Relieve Gum Irritation

Menthol to Soothe Gums

Safety Sealed

Tube Tip

Fast Acting Gel

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

OJFC-32503-07.jpg

BENZOCAINE, MENTHOL, ZINC CHLORIDE 
orajel instant pain relief severe gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-769
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 CATION2.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GELATIN (UNII: 2G86QN327L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-769-251 in 1 CARTON04/26/201712/17/2021
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 finalpart35604/26/201712/17/2021
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-769)

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