NDC 70797-307 Dr. Talbots Oral Comfort Pack

Pain Fever Relief And Soothing Gel

NDC Product Code 70797-307

NDC CODE: 70797-307

Proprietary Name: Dr. Talbots Oral Comfort Pack What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pain Fever Relief And Soothing Gel What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 70797 - Talbot's Pharmaceuticals Family Products, Llc.

NDC 70797-307-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 15 g in 1 TUBE (70797-240-15) * 1 BOTTLE in 1 BOTTLE (70797-315-01) > 118 mL in 1 BOTTLE (70797-315-04)

NDC Product Information

Dr. Talbots Oral Comfort Pack with NDC 70797-307 is a a human over the counter drug product labeled by Talbot's Pharmaceuticals Family Products, Llc.. The generic name of Dr. Talbots Oral Comfort Pack is pain fever relief and soothing gel. The product's dosage form is kit and is administered via oral; topical form.

Labeler Name: Talbot's Pharmaceuticals Family Products, Llc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBIC ACID (UNII: X045WJ989B)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • CONCORD GRAPE JUICE (UNII: F7039Q79LP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Talbot's Pharmaceuticals Family Products, Llc.
Labeler Code: 70797
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-06-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dr. Talbots Oral Comfort Pack Product Label Images

Dr. Talbots Oral Comfort Pack Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active IngredientsCalendula officinalis 12X HPUSChamomilla 12X HPUSEchinacea angustifolia 12X HPUSEupatorium perfoliatum 12X HPUSHepar sulphuris calcareum 12X HPUSSulphur 12X HPUSCell SaltsFerrum phosphoricum 12X HPUSKali muriaticum 6X HPUS

Active ingredientsArnica 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.

Otc - Purpose

PurposeReduces inflammationHypersensitivity, irritabilityWeakness, aching bodyAching pain, flu-like symptomsHypersensitive to cold, chillsHeadache, symptoms of feverSymptoms of feverGlandular swellings, inflammation

Purpose†sore gumssensitive gumspain associated with irritability

Indications & Usage

  • Temporarily relievesirritabilitycold chillsflu-like symptomsfeverbody achegeneral sorenessswollen 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, consult your doctor before use.

Otc - 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.

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

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 kgs1.25 ml every 2 hours, reduce frequency when symptoms improveChildren 19 - 29 lbs or 9 - 13 kgs2.5 ml every 2 hours, reduce frequency when symptoms improveChildren 30 - 90 lbs or 14 - 41 kgs5 ml every 2 hours, reduce frequency when symptoms improve

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.

Inactive Ingredient

Inactive ingredientsCitric acid, glycerin, grape juice, potassium sorbate, purified water

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

Otc - Questions

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

Other Safety Information

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

* Please review the disclaimer below.