Your browser does not support JavaScript! RITE AID BABY CARE (BENZOCAINE) GEL, DENTIFRICE [RITE AID]
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RITE AID BABY CARE (benzocaine) gel, dentifrice
[Rite Aid]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Benzocaine 7.5% ...................................................................... Oral pain reliever

Use

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

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 told to do so by a dentist or doctor.
  • When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your dentist or doctor.
  • Stop use and ask a doctor if sore mouth symptoms do not get better 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 gel
  • apply to affected area up to four 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

FD&C Red 40, Flavor, Glycerin, Polyethylene Glycols, Purified Water, Sodium Saccharin, Sorbic Acid, Sorbitol

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Carton label

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Tube Label

• 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: consult a dentist or doctor
RITE AID  BABY CARE
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-1031
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 3350 
SACCHARIN SODIUM 
SORBITOL 
GLYCERIN 
SORBIC ACID 
FD&C RED NO. 40 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Characteristic Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1031-91 in 1 CARTON
1NDC:11822-1031-214.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/20/2011
Labeler - Rite Aid (014578892)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(11822-1031), pack(11822-1031)

Revised: 1/2013
 
Rite Aid

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