CVS PHARMACY NIGHTTIME ORAL PAIN RELIEF- benzocaine gel, dentifrice 
CVS Pharmacy

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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CVS Ext Str Nighttime Oral Pain Relief

Active ingredient

Benzocaine 10.0% ..................................Purpose: Oral pain reliever

Uses

temporarily relieves sore gums due to teething in infants and children 4 months of age or older

Allergy alert: do not use this product if your baby has 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 a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens

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

Directions

• wash hands

• cut open tip of tube on scoremark

• use your fingertip or cotton applicator to apply a small pea-size amount of product

•apply to affected area up to 4 times daily or as directed by a dentist or doctor. For infants under 4 months of age ask a dentist or doctor.

Other Information

do not use if tip is cut prior to opening.

Inactive ingredients

Cellulose Gum, FD&C Red No.40, Flavor, Gelatin, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin

• use your fingertip or cotton applicator to apply a small pea-size amount of product

•apply to affected area up to 4 times daily or as directed by a dentist or doctor. For infants under 4 months of age ask a dentist or doctor.

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Carton label

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Tube Label

CVS PHARMACY  NIGHTTIME ORAL PAIN RELIEF
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-833
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PECTIN (UNII: 89NA02M4RX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
Colorpink (Pink to Redish orange) Score    
ShapeSize
FlavorCHERRY (Cherry, medicinal) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-833-191 in 1 CARTON08/01/201302/15/2019
1NDC:59779-833-125.1 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/01/201302/15/2019
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(59779-833)

Revised: 2/2019
 
CVS Pharmacy