NDC 72705-100 Frida Mom Perineal Cooling Pad Liners

Witch Hazel

NDC Product Code 72705-100

NDC 72705-100-01

Package Description: 24 CLOTH in 1 POUCH

NDC Product Information

Frida Mom Perineal Cooling Pad Liners with NDC 72705-100 is a a human over the counter drug product labeled by Fridababy, Llc. The generic name of Frida Mom Perineal Cooling Pad Liners is witch hazel. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Fridababy, Llc

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.


Frida Mom Perineal Cooling Pad Liners Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • WITCH HAZEL .5 g/1

Administration Route(s)

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

  • 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: Fridababy, Llc
Labeler Code: 72705
FDA Application Number: part346 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-01-2019 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: 12-31-2020 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.

Frida Mom Perineal Cooling Pad Liners Product Label Images

Frida Mom Perineal Cooling Pad Liners 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

Other

Perineal Cooling Pad LinersDrug Facts

Perineal Healing FoamDrug Facts

Active Ingredient

Witch Hazel 50%

Witch Hazel 50%

Purpose

Astringent

Astringent

Uses

  • Helps relieve pain and swelling from hemorrhoids and childbirth.Temporary relief from: IrritationBurningDiscomfort

  • Helps relieve pain and swelling from hemorrhoids and childbirth.Temporary relief from: IrritationBurningDiscomfort

Warnings

For external use only

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.

  • 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.

  • Rectal bleeding occurs.Condition worsens or does not improve within 7 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

  • 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.

Other Information

  • Store at room temperatureClose lid after every use to retain moisture.Discard after every use.Not flushable.

  • Store at room temperatureSingle use per wipe

Inactive Ingredients

Water, glycerin, alcohol, sodium lauroamphoacetate, chamomilla recutita extract, caprylic/capric triglyceride, tocopherol, phenoxyethanol, benzoic acid, dehydroacetic acid, sodium benzoate, citric acid, mentha piperita oil, menthyl lactate, sodium citrate

Water, glycerin, alcohol, sodium lauroamphoacetate, chamomilla recutita extract, caprylic/capric triglyceride, tocopherol, phenoxyethanol, benzoic acid, dehydroacetic acid, sodium benzoate, citric acid, mentha piperita oil, sodium citrate

* Please review the disclaimer below.

Previous Code
72701-104
Next Code
72705-150