Frida Mom Labor And Delivery Plus Postpartum Recovery
Witch Hazel
Fridababy, Llc
Human Otc Drug
NDC 72705-251Frida Mom Labor And Delivery Plus Postpartum Recovery also known as Witch Hazel is a human otc drug labeled by 'Fridababy, Llc'. National Drug Code (NDC) number for Frida Mom Labor And Delivery Plus Postpartum Recovery is 72705-251. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Frida Mom Labor And Delivery Plus Postpartum Recovery drug includes . The currest status of Frida Mom Labor And Delivery Plus Postpartum Recovery drug is Active.
Drug Information:
| Drug NDC: | 72705-251 |
| 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: | Frida Mom Labor And Delivery Plus Postpartum Recovery |
| 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: | Witch Hazel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fridababy, Llc |
| 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: | |
| 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: | OTC MONOGRAPH FINAL |
| 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: | 01 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| Application Number: | part346 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | Fridababy, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 844379
2166922
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 72705-251-02 | 1 KIT in 1 CARTON (72705-251-02) * 24 CLOTH in 1 POUCH (72705-100-01) * 141.75 g in 1 BOTTLE, PUMP (72705-150-01) | 01 May, 2019 | 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 astringent
Purpose astringent
Product Elements:
Frida mom labor and delivery plus postpartum recovery witch hazel frida mom perineal cooling pad liners witch hazel witch hazel witch hazel water glycerin alcohol sodium lauroamphoacetate medium-chain triglycerides tocopherol phenoxyethanol benzoic acid dehydroacetic acid sodium benzoate citric acid monohydrate peppermint oil menthyl lactate, (-)- sodium citrate, unspecified form frida mom perineal healing witch hazel witch hazel witch hazel water glycerin alcohol sodium lauroamphoacetate medium-chain triglycerides tocopherol phenoxyethanol benzoic acid dehydroacetic acid sodium benzoate citric acid monohydrate peppermint oil sodium citrate, unspecified form
Indications and Usage:
Uses helps relieve pain and swelling from hemorrhoids and childbirth. temporary relief from: irritation burning discomfort
Uses helps relieve pain and swelling from hemorrhoids and childbirth. temporary relief from: irritation burning discomfort
Warnings:
Warnings for external use only when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator. stop use and ask a doctor if rectal bleeding occurs. condition worsens or does not improve within 7 days. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator. stop use and ask a doctor if rectal bleeding occurs. condition worsens or does not improve within 7 days. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator.
When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not exceed the recommended daily dosage unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator.
Dosage and Administration:
Directions remove one pad liner from pouch and place on top of maxi pad. close lid after use to retain moisture. replace pad liner with each maxi pad change.
Directions cleanse the affected area using a peri bottle or mild soap and warm water. add foam on top of each new pad or pad liner for healing relief. children under 12 years of age: consult a doctor before use.
Stop Use:
Stop use and ask a doctor if rectal bleeding occurs. condition worsens or does not improve within 7 days.
Stop use and ask a doctor if rectal bleeding occurs. condition worsens or does not improve within 7 days.
Package Label Principal Display Panel:
Principal display panel - kit carton frida mom labor and delivery + postpartum recovery kit the motherload of labor + recovery must-haves, from first contractions to first post-baby toilet trip you've hit the motherload pack + push bathroom essentials bag delivery and nursing gown + socks 1 gown + 1 pair of socks + cleanse upside down peri bottle 1 peri bottle cover disposable postpartum underwear 4 pairs cool + absorb instant ice maxi pads 4 pads soothe + relieve pain perineal cooling pad liners 24 witch hazel liners perineal healing foam witch hazel net 5 fl. oz. postpartum principal display panel - kit carton