Dosage And Administration

Dosage And Administration
SPL v3
SPL
SPL Set ID 33860fde-8f9e-8fbb-e063-6294a90aae4a
Route
TOPICAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Propylene Glycol Castor Oil Peg-40 Hydrogenated Castor Oil Xanthan Gum Glycerin Rosemary Oil Panax Notoginseng Root

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2025-09-20


Medication Information

Indications and Usage

Dosage and Administration

Section 51727-6

Section 55105-1

Section 55106-9

For External Use Only.

If Swallowed, Get Medical Help Or Contact Poison Control Center Right Away.

You Become Pregnant, Or Are Planning to Become Pregnant, While Using the Product.

Avoid Contact With Eyes. Lf the Product Gets Into the Eye,flush With Water for 15 Minutes.

Store in A Cool, Shaded Place Away From Directsunlight. Store At Room Temperature Between15 30°c(59 86°f)

For External Use Only.when Using This Product, Avoidgetting Into Eyes. Lf Contact Occurs, Rinse Thoroughlywith Water. Lfskin Irritation Occurs, Wash Product Offand Consult A Physician.when First Applying Thisproduct,you May Experience A Slight Tingling Sensation.this Is An Indication That the Product Is Working. Lf Thesensation Is Prolonged Or Becomes Unpleasant,discontinue Use and Consult A Physician.


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 51727-6 (51727-6)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

For External Use Only. (For external use only.)

If Swallowed, Get Medical Help Or Contact Poison Control Center Right Away. (If swallowed, get medical help or contact Poison Control Center right away.)

You Become Pregnant, Or Are Planning to Become Pregnant, While Using the Product. (You become pregnant, or are planning to become pregnant, while using the product.)

Avoid Contact With Eyes. Lf the Product Gets Into the Eye,flush With Water for 15 Minutes. (Avoid contact with eyes. lf the product gets into the eye,flush with water for 15 minutes.)

Store in A Cool, Shaded Place Away From Directsunlight. Store At Room Temperature Between15 30°c(59 86°f) (Store in a cool, shaded place away from directsunlight. Store at room temperature between15-30°C(59-86°F))

For External Use Only.when Using This Product, Avoidgetting Into Eyes. Lf Contact Occurs, Rinse Thoroughlywith Water. Lfskin Irritation Occurs, Wash Product Offand Consult A Physician.when First Applying Thisproduct,you May Experience A Slight Tingling Sensation.this Is An Indication That the Product Is Working. Lf Thesensation Is Prolonged Or Becomes Unpleasant,discontinue Use and Consult A Physician. (For external use only.When using this product, avoidgetting into eyes. lf contact occurs, rinse thoroughlywith water. lfskin irritation occurs, wash product offand consult a physician.When first applying thisproduct,you may experience a slight tingling sensation.This is an indication that the product is working. lf thesensation is prolonged or becomes unpleasant,discontinue use and consult a physician.)


Advanced Ingredient Data


Raw Label Data

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