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Budpak Baby Teething Oral Pain Reliever

Dosage form: gel
Ingredients: BENZOCAINE 7.5g in 100g
Labeler: Budpak Inc.
NDC Code: 27293-015

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.

Budpak Baby Teething Oral Pain Reliever Gel

Active Ingredient

Benzocaine 7.5%

Purpose

Oral pain reliever

Use

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, benzocaine 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 if

  • 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 cases of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

  • do not use if tube safety seal is broken
  • wash hands
  • break seal on tube
  • use your fingertip or cotton applicator to apply a small pea-size amount of Budpak 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°C to 25 °C (59°F to 77°F)
  • Lot No. & Exp. Date: see crimp of tube

Inactive Ingredients

Glycyrrhizin Ammoniated, Glycerin, Polyethylene glycol, Purified water, Sodium saccharin, Sorbic acid, Sorbitol, Flavor, Red #40.

PRINCIPAL DISPLAY PANEL

BUDPAK BABY TEETHING PAIN RELIEVER GEL

Benzocaine 7.5%

NET WT 0.5 OZ. (14 g)

BUDPAK BABY TEETHING ORAL PAIN RELIEVER 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SACCHARIN SODIUM 
SORBIC ACID 
SORBITOL 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:27293-015-011 TUBE in 1 BOX
1NDC:27293-015-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/26/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-015)

Revised: 12/2013
 
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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