WALGREENS BABY TEETHING- benzocaine gel, dentifrice 
Walgreens

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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Walgreens Baby Teething Gel Cherry

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

• 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

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Carton label

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Tube Label

WALGREENS  BABY TEETHING
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6230
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (Characteristic Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6230-091 in 1 CARTON01/20/201103/06/2019
1NDC:0363-6230-0214 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 finalpart35601/20/201103/06/2019
Labeler - Walgreens (008965063)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(0363-6230) , pack(0363-6230)

Revised: 3/2019
 
Walgreens