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Sheffield Baby Teething Gel

Dosage form: gel
Ingredients: BENZOCAINE 75mg in 1g
Labeler: Faria LLC dba Sheffield Pharmaceuticals
NDC Code: 11527-061

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

Oral Teething Pain Reliever

Uses
  • for temporary relief of sore gums due to teething in infants and children under 4 months of age and older

Warnings

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 persist, consult a doctor.

Stop use and ask a doctor if
  • 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
  • do not use tube if it is cut prior to opening
  • cut open tip of tube on score mark
  • use your fingertip or cotton applicator to apply a small pea-size amount of teething gel
  • apply to affected area up to four times daily or as directed by a dentist or physician
  • for infants under 4 months of age, there is no recommended dose or treatment , except under the advice and supervision of a dentist or doctor.

Other information
  • store at a controlled room temperature 59°-86°F (15°-30°C)

Inactive ingredients

D&C Yellow No. 10, FD&C Red No. 40,  Flavor, Glycerin,  PEG 6, PEG 8, PEG 32, PEG 75, Sodium Saccharin, Sorbic Acid,  Purified water

Principal Display Panel – 0.33oz Carton Label

NDC 11527-061-47

Baby Teething Gel

Benzocaine 7.5% NET WT. 0.33 OZ (9.35g)

Oral Pain Reliever for Teething

Dr. Sheffield's

SHEAF-FIELD

Made in the USA

Principal Display Panel – 0.33oz Tube Label

NDC 11527-061-47

Baby Teething Gel

Benzocaine 7.5%

Cherry flavor Oral Pain Reliever for Teething

Dr. Sheffield's

SHEAF-FIELD

Made in the USA

NET WT. 0.33 OZ (9.35g)

SHEFFIELD BABY TEETHING GEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-061
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 1500 
POLYETHYLENE GLYCOL 3350 
Saccharin Sodium 
Sorbic Acid 
WATER 
D&C YELLOW NO. 10 
GLYCERIN 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11527-061-471 TUBE in 1 CARTON
19.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/17/2003
Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(11527-061)

 
Faria LLC dba Sheffield Pharmaceuticals

Medically reviewed on Nov 20, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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