SHEFFIELD BABY TEETHING GEL- benzocaine gel

Sheffield Baby Teething Gel by

Drug Labeling and Warnings

Sheffield Baby Teething Gel by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SHEFFIELD BABY TEETHING GEL 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbic Acid (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-061-47	1 in 1 CARTON	06/17/2003	12/31/2020
1		9.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/17/2003

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-061)