Nuby Teething Gel: Package Insert and Label Information

NUBY TEETHING GEL- eugenol 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.

Eugenol 0.8%

active ingredient
(click image for full-size original)

Purpose

Oral pain reliever

PurposePurpose

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 childrenKeep 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

warningswarnings

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 & AdministrationDosage & 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 ingredientinactive ingredient

Use

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

UseUse

Principal Display Panel

PDP

NUBY TEETHING GEL
teething gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71552-231
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUGENOL (EUGENOL) EUGENOL 8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71552-231-12 12 CARTON in 1 CARTON contains a CARTON
1 3 BLISTER PACK in 1 CARTON This package is contained within the CARTON (71552-231-12) and contains a BLISTER PACK
1 1 TUBE in 1 BLISTER PACK This package is contained within the CARTON and contains a TUBE (71552-231-15)
1 NDC:71552-231-15 15 g in 1 TUBE This package is contained within a BLISTER PACK and a CARTON and a CARTON (71552-231-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/28/2017
Labeler — Europharma Concepts limited (896333478)

Revised: 06/2017 Europharma Concepts limited

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