Teething Gel

Drug Labeling and Warnings

Drug Details [pdf]

NUBY TEETHING GEL- teething gel gel 
Talbot’s Pharmaceuticals Family Products, LLC.

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.

----------

Teething Gel

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.

Use

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

Warning

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, GlycerylCaprylate, GlycerylUndecelynate, Lactic Acid, Potassium Sorbate, Propanediol, Stevia Rebaudiana Extract, Xanthan Gum

Active Ingredient

Eugenol 1.3% (extracted from Clove Plant)

Principal Display Panel

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)	Â

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70797-230-25	24 in 1 CARTON	12/01/2016	04/11/2018
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	04/11/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Longwell Baby Products Co Ltd		527868252	label(70797-230) , pack(70797-230)

Revised: 9/2019

Document Id: 934ed35a-66f9-24e9-e053-2995a90a5162

34390-5

Set id: 427ae0ef-0d4b-025e-e054-00144ff8d46c

Version: 2

Effective Time: 20190924

 

Talbotâ€