Sheffield Baby Teething Gel description, usages, side effects, indications, overdosage, supplying and lots more!

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Sheffield Baby Teething Gel

Faria LLC dba Sheffield Pharmaceuticals


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Sheffield Baby Teething Gel

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

Sheffield Baby Teething Gel

BENZOCAINE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11527-061
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 75 mg

Inactive Ingredients

Ingredient Name Strength
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9.35 in 1 TUBE
2 NDC:11527-061-47 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2003-06-17


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Be sure to consult your doctor before taking any medication!
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