NUBY TEETHING GEL- teething gel gel

Nuby Teething Gel by

Drug Labeling and Warnings

Nuby Teething Gel by is a Otc medication manufactured, distributed, or labeled by Talbot’s Pharmaceuticals Family Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Eugenol 1.3% (extracted from Clove Plant)

Purpose

Oral pain reliever

Keep out of reach of children

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Warnings

Allergy alert do not use this product if your baby has a history of allergy to clove, its component eugenol, or to Balsam of Peru.

Do not use

more than directed

for more than 7 days unless directed 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 your physician.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days

irritation, pain or redness does not go away

swelling, rash or fever develops

Directions

Wash hands before use.

Cut open tip of tube on score mark.

Use your finger tip or cotton applicator to gently apply a small pea-size amount of Nuby Teething Gel to the affected area up to 4 times daily or as directed by a physician or healthcare provider.

For infants under 4 months of age, ask a dentist or doctor before use.

Inactive Ingredients

Aqua (Water), Betaine, Bioflavonoids, Citric Acid, Flavor (Natural), Glycerin, Glyceryl Caprylate, Glyceryl Undecelynate, Lactic Acid, Potassium Sorbate, Propanediol, Stevia Rebaudiana Extract, Xanthan Gum

Use

For the temporary relief of sore gums due to teething in infants and children 4 months of age and older.

Principal Display Panel

INGREDIENTS AND APPEARANCE

NUBY TEETHING GEL 
teething gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70797-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW)	EUGENOL	13 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70797-230-24	24 in 1 CARTON	12/01/2016
1		4 in 1 CARTON
1		1 in 1 BLISTER PACK
1	NDC: 70797-230-15	15 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	12/01/2016

Labeler - Talbot’s Pharmaceuticals Family Products, LLC. (078855555)