DR. TALBOTS ORAL COMFORT PACK- pain fever relief and soothing gel kit

Dr. Talbots Oral Comfort Pack by

Drug Labeling and Warnings

Dr. Talbots Oral Comfort Pack by is a Homeopathic medication manufactured, distributed, or labeled by Talbot's Pharmaceuticals Family Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

INDICATIONS & USAGE

Temporarily relieves

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

WARNINGS

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, consult your doctor before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or Comments?

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

ACTIVE INGREDIENT

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

Purpose†

sore gums

sensitive gums

pain associated with irritability

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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	Marketing Start Date	Marketing End Date
1	NDC: 70797-307-01	1 in 1 PACKAGE, COMBINATION; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	07/06/2020

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	30 [hp_X]  in 15 g
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	12 [hp_X]  in 15 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [hp_X]  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70797-240-15	15 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	12 [hp_X]  in 118 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 118 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 118 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	12 [hp_X]  in 118 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	12 [hp_X]  in 118 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X]  in 118 mL
COSMOS SULPHUREUS FLOWERING TOP (UNII: WKB165X336) (COSMOS SULPHUREUS FLOWERING TOP - UNII:WKB165X336)	COSMOS SULPHUREUS FLOWERING TOP	12 [hp_X]  in 118 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	6 [hp_X]  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
CONCORD GRAPE JUICE (UNII: F7039Q79LP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70797-315-01	1 in 1 BOTTLE
1	NDC: 70797-315-04	118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

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)