Label: NUBY TEETHING GEL- teething gel gel
- NDC Code(s): 70797-230-15, 70797-230-24
- Packager: Talbot’s Pharmaceuticals Family Products, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 28, 2016
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- Active Ingredient
Eugenol 1.3% (extracted from Clove Plant)
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.
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
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
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)