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

  • NDC Code(s): 71240-240-15, 71240-307-01, 71240-315-01, 71240-315-04
  • Packager: Ningbo Longwell Baby Products Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated February 22, 2022

If you are a consumer or patient please visit this version.

  • 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

    30007

  • INGREDIENTS AND APPEARANCE
    DR. TALBOTS ORAL COMFORT PACK 
    pain fever relief and soothing gel kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71240-307
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71240-307-011 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 QuantityTotal Product Quantity
    Part 10 TUBE 2 g
    Part 20 BOTTLE 2 mL  in 2 
    Part 1 of 2
    NUBY SOOTHING GEL 
    soothing gel gel
    Product Information
    Item Code (Source)NDC:71240-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT30 [hp_X]  in 15 g
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 15 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA12 [hp_X]  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBIC ACID (UNII: X045WJ989B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71240-240-1515 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/06/2020
    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:71240-315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COSMOS SULPHUREUS FLOWERING TOP (UNII: WKB165X336) (COSMOS SULPHUREUS FLOWERING TOP - UNII:WKB165X336) COSMOS SULPHUREUS FLOWERING TOP12 [hp_X]  in 118 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 118 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]  in 118 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 118 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA12 [hp_X]  in 118 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE6 [hp_X]  in 118 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP12 [hp_X]  in 118 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    CONCORD GRAPE JUICE (UNII: F7039Q79LP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71240-315-011 in 1 CONTAINER
    1NDC:71240-315-04118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/06/2020
    Labeler - Ningbo Longwell Baby Products Co.,Ltd. (527868252)