NDC 70550-578 Keranique Hair Regrowth Treatment For Women

Minoxidil 2%

NDC Product Code 70550-578

NDC 70550-578-01

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 60 mL in 1 BOTTLE, SPRAY

NDC 70550-578-02

Package Description: 2 BOTTLE, SPRAY in 1 BOX > 60 mL in 1 BOTTLE, SPRAY

NDC 70550-578-03

Package Description: 3 BOTTLE, SPRAY in 1 BOX > 60 mL in 1 BOTTLE, SPRAY

NDC Product Information

Keranique Hair Regrowth Treatment For Women with NDC 70550-578 is a a human over the counter drug product labeled by International Hair Institute. The generic name of Keranique Hair Regrowth Treatment For Women is minoxidil 2%. The product's dosage form is spray and is administered via topical form.

Labeler Name: International Hair Institute

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Keranique Hair Regrowth Treatment For Women 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.

  • MINOXIDIL 2 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)

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: International Hair Institute
Labeler Code: 70550
FDA Application Number: ANDA078176 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 07-10-2019 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.

Keranique Hair Regrowth Treatment For Women Product Label Images

Keranique Hair Regrowth Treatment For Women 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

Minoxidil 2% w/v

Indications & Usage

Use to regrow hair on the scalp

Otc - Purpose

Hair regrowth treatment


For external use only.Flamable: Keep away from fire of flame.

Otc - Do Not Use

  • Do not use if:Your degree of hair loss is different than shown on the side of this carton, because this product may not work for youYou have no family history of hair lossYour hair loss is sudden and/or patchyYour hair loss is associated with childbirthYou do not know the reason for your hair lossYou are under 18 years of age. Do not use on babies or childrenYour scalp is red, inflamed, infected, irritated, or painfulYou use other medicines on the scalp

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - When Using

  • When using this productDo not apply on other parts of the bodyAvoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap waterSome people have expereinced changes in hair color and/or textureIt takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.The amount of hair regrowth is different for each person. This product will not work for everyone.

Otc - Stop Use

  • Stop use and ask a doctor ifChest pain, rapid heart beat, faintness, or dissiness occursSudden, unexplained weight gain occursYour hands of feet swellScalp irritation or redness occursYou get unwanted facial hair growthYou do not see hair regrowth in 4 months

Otc - Pregnancy Or Breast Feeding

May be harmful if used when pregnant or breast-feeding.

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.


  • Prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss areausing more or more often will not improve resultscontinued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other Information

  • See hair loss pictures on the side of this cartonBefore use, read all information on carton and enclosed leafletKeep the carton. It contains important informationIn clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)

Inactive Ingredient

Alcohol, Propylene Glycol, Purified Water

Otc - Questions

Questions or comments?1-888-237-4131Open 24 hours a day, 7 days a week. Visit website: www.keranique.com

* Please review the disclaimer below.