Dr. Talbots Oral Comfort Pack
Pain Fever Relief And Soothing Gel
Ningbo Longwell Baby Products Co.,ltd.
Human Otc Drug
NDC 71240-307Dr. Talbots Oral Comfort Pack also known as Pain Fever Relief And Soothing Gel is a human otc drug labeled by 'Ningbo Longwell Baby Products Co.,ltd.'. National Drug Code (NDC) number for Dr. Talbots Oral Comfort Pack is 71240-307. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Dr. Talbots Oral Comfort Pack drug includes . The currest status of Dr. Talbots Oral Comfort Pack drug is Active.
Drug Information:
| Drug NDC: | 71240-307 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dr. Talbots Oral Comfort Pack |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Pain Fever Relief And Soothing Gel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ningbo Longwell Baby Products Co.,ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 06 Jul, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Ningbo Longwell Baby Products Co.,Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0370797300073
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71240-307-01 | 1 KIT in 1 PACKAGE, COMBINATION (71240-307-01) * 1 BOTTLE in 1 CONTAINER (71240-315-01) / 118 mL in 1 BOTTLE (71240-315-04) * 15 g in 1 TUBE (71240-240-15) | 06 Jul, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
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
Purposeâ sore gums sensitive gums pain associated with irritability
Product Elements:
Dr. talbots oral comfort pack pain fever relief and soothing gel nuby soothing gel soothing gel arnica montana root arnica montana root tribasic calcium phosphate calcium cation xanthan gum matricaria recutita matricaria recutita water sodium benzoate potassium sorbate sorbic acid glycerin dr. talbots pain fever relief calendula officinalis, chamomilla, echinacea angustifolia, eupatorium perfoliatum, hepar sulphuris calcareum, sulphur, ferrum phosphoricum, kali muriaticum cosmos sulphureus flowering top cosmos sulphureus flowering top calcium sulfide calcium sulfide concord grape juice citric acid monohydrate calendula officinalis flowering top calendula officinalis flowering top ferrosoferric phosphate ferrosoferric phosphate echinacea angustifolia echinacea angustifolia potassium sorbate glycerin potassium chloride potassium cation water eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top matricaria chamomilla matricaria recutita
Indications and 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.
Dosage and 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
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.
Package Label Principal Display Panel:
30007
Further Questions:
Questions or comments? call us at 1-855-366-7755 (u.s.a. only) m-f 8am-5pm cst