NUBY TEETHING GEL- teething gel gel 
Europharma Concepts limited

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.

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Active Ingredient

Eugenol 0.8%

active ingredient

Purpose

Oral pain reliever

Purpose

Keep out of reach of children

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

Keep out of reach of children

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

warnings

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.

Dosage & Administration

Inactive Ingredients

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

inactive ingredient

Use

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

Use

Principal Display Panel

PDP

NUBY TEETHING GEL 
teething gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71552-231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71552-231-1212 in 1 CARTON06/28/2017
13 in 1 CARTON
11 in 1 BLISTER PACK
1NDC:71552-231-1515 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/28/2017
Labeler - Europharma Concepts limited (896333478)

Revised: 6/2017
Document Id: 52a6d991-fefc-3df2-e054-00144ff8d46c
Set id: 53082bd5-12df-6587-e054-00144ff88e88
Version: 2
Effective Time: 20170623
 
Europharma Concepts limited