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Baby Teething Oral Pain Reliever

Dosage form: gel
Ingredients: BENZOCAINE 7.5g in 100g
Labeler: Budpak Inc.
NDC Code: 27293-013

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.

Drug Facts

Active Ingredient
Benzocaine 7.5%

Purpose
Anesthetic

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

Warnings
  • Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Do not use
  • for more than 7 days unless told to do so by a physician 
  • more than directed

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 physician

Stop using and ask a dentist or physician

  • sore mouth symptoms do not get better in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops
   

Keep out of reach of children. In case of overdose or allergic reaction contact a Poison Control Center right away

Directions

  • wash your hands
  • use your fingertip or cotton applicator to apply a small pea-size amount of Budpack Baby Teething Gel Medicine.
  • Apply to affected area up to 4 times daily or as directed by a dentist or physician.
  • for infants under 4 months of age, ask a doctor

Other information

  •      Store at 15 to 25 C (59-77F)
   

Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40


Package Label

BABY TEETHING ORAL PAIN RELIEVER 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
SORBIC ACID 
METHYLPARABEN 
PROPYLPARABEN 
FD&C YELLOW NO. 5 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:27293-013-011 TUBE (TUBE) in 1 BOX
1NDC:27293-013-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2010
Labeler - Budpak Inc. (183224849)
Establishment
NameAddressID/FEIOperations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture

Revised: 05/2010
 
Budpak Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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