RITE AID BABY CARE- benzocaine gel, dentifrice 
Rite Aid

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 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

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

Directions

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 Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1031
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBIC ACID (UNII: X045WJ989B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Characteristic Cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11822-1031-9 1 in 1 CARTON
1 NDC:11822-1031-2 14.0 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/20/2011
Labeler - Rite Aid (014578892)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(11822-1031) , pack(11822-1031)

Revised: 1/2013
Document Id: c03558fb-184a-40c8-91c5-9b664abfacb4
Set id: e105ef9f-b596-410f-954d-523e392176af
Version: 1
Effective Time: 20130109
 
Rite Aid