Dr. Talbots Oral Comfort Pack: Homeopathic Product Information

DR. TALBOTS ORAL COMFORT PACK- pain fever relief and soothing gel
Talbot’s Pharmaceuticals Family Products, LLC.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Active Ingredients

Calendula officinalis 12X HPUS

Chamomilla 12X HPUS

Echinacea angustifolia 12X HPUS

Eupatorium perfoliatum 12X HPUS

Hepar sulphuris calcareum 12X HPUS

Sulphur 12X HPUS

Cell Salts

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Purpose

Reduces inflammation

Hypersensitivity, irritability

Weakness, aching body

Aching pain, flu-like symptoms

Hypersensitive to cold, chills

Headache, symptoms of fever

Symptoms of fever

Glandular swellings, inflammation

Temporarily relieves

  • irritability
  • cold chills
  • flu-like symptoms
  • fever
  • body ache
  • general soreness
  • swollen glands

Stop use and ask doctor if:

fever wosens or lasts more than 2 days
pain gets worse or lasts more than 7 days
other symptoms persist for more than 7 days or worsen
Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
Please consult your physician immediately for a worsening condition.

If pregnant or breastfeeding , consult your doctor before use.

Keep out of reach of children. In case of overdose (or accidental ingestion), get medical help or contact a Poison Control Center right away.

Shake before use, natural juice may settle
Measure only with the dosing syringe provided
Do not use dosing syringe with other products
On dosing syringe, weight is specific to product
On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 — 18 lbs or 3 — 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 — 29 lbs or 9 — 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 — 90 lbs or 14 — 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Questions or Comments?

Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST

Active ingredients

Arnica Montana, radix 30X HPUS 3.33%

Calcarea Phosphorica 12X HPUS 3.33%

Chamomilla 12X HPUS 3.33%

The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose†

sore gums

sensitive gums

pain associated with irritability

Keep this and all medications out of the reach of children. In case of accidental overdose contact a medical professional or a Poison Control Center immediately.

Directions

• Wash hands before use.

• Cut open tip of tube on score mark.

• Use your fingertip or cotton applicator to gently apply a small pea-size amount of Dr. Talbot’s Soothing Gel to the affected area every 15 minutes as necessary or as directed by a physician or healthcare provider.

Other Information

Tamper evident — Do not use if tube tip is cut prior to opening.

Inactive ingredients

Aqua (Purified Water), Potassium Sorbate NF, Sodium Benzoate NF, Sorbic Acid NF, Vegetable Glycerin USP, Xanthan Gum NF.

PDP
(click image for full-size original)

DR. TALBOTS ORAL COMFORT PACK
pain fever relief and soothing gel kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70797-307
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70797-307-01 1 KIT in 1 PACKAGE, COMBINATION None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 0 TUBE 2 g
Part 2 0 BOTTLE 2 mL in 2
Part 1 of 2
NUBY SOOTHING GEL
soothing gel gel
Product Information
Item Code (Source) NDC:70797-240
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 30 [hp_X] in 15 g
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION 12 [hp_X] in 15 g
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 12 [hp_X] in 15 g
Inactive Ingredients
Ingredient Name Strength
WATER
POTASSIUM SORBATE
SODIUM BENZOATE
SORBIC ACID
XANTHAN GUM
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70797-240-15 15 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/06/2020
Part 2 of 2
DR. TALBOTS PAIN FEVER RELIEF
calendula officinalis, chamomilla, echinacea angustifolia, eupatorium perfoliatum, hepar sulphuris calcareum, sulphur, ferrum phosphoricum, kali muriaticum liquid
Product Information
Item Code (Source) NDC:70797-315
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 12 [hp_X] in 118 mL
FERROSOFERRIC PHOSPHATE (FERROSOFERRIC PHOSPHATE) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 118 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 118 mL
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 12 [hp_X] in 118 mL
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 118 mL
MATRICARIA CHAMOMILLA (MATRICARIA RECUTITA) MATRICARIA CHAMOMILLA 12 [hp_X] in 118 mL
COSMOS SULPHUREUS FLOWERING TOP (COSMOS SULPHUREUS FLOWERING TOP) COSMOS SULPHUREUS FLOWERING TOP 12 [hp_X] in 118 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 6 [hp_X] in 118 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
WATER
CONCORD GRAPE JUICE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70797-315-01 1 BOTTLE in 1 BOTTLE contains a BOTTLE (70797-315-04)
1 NDC:70797-315-04 118 mL in 1 BOTTLE This package is contained within the BOTTLE (70797-315-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/06/2020
Labeler — Talbot’s Pharmaceuticals Family Products, LLC. (078855555)

Revised: 10/2021 Talbot’s Pharmaceuticals Family Products, LLC.

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