SPL v1
SPL
SPL Set ID 3fb7dbd0-0eb9-cbee-e063-6294a90a63c2
Route
TOPICAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (2 mg)
Inactive Ingredients
Hydrolyzed Porcine Collagen (enzymatic; 3000 Mw) Methylisothiazolinone Water Sodium Laureth Sulfate Cocamide Dea Propylene Glycol 1,2-distearate Citric Acid Methylchloroisothiazolinone Sodium Chloride Betaine Benzyl Alcohol Rosemary Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-09-26 Until 2027-09-26

Description

Apply to wet hair, lather and rinse, repeat if necessary.


Medication Information

Warnings and Precautions

Avoid eye contact, if occurs rinse eyes thoroughly with water. If develop any allergic reaction, discontinue its use. Keep out reach of children. For external use only.

Indications and Usage

Apply to wet hair, lather and rinse, repeat if necessary.

Dosage and Administration

Apply to wet hair, lather and rinse, repeat if necessary.

Description

Apply to wet hair, lather and rinse, repeat if necessary.

Section 50565-1

Keep out reach of children. For external use only.

Section 50744-2

Customer Service USA (917)508-6002

Customer Service RD (809)379-0900

www.mkcosmeticos.com

Section 51727-6

Water, Sodium Laureth Sulfate, Cocamide DEA, Betaine, Sodium Chloride, Propylene Glycol, Rosemary Extract, Hydrolyzed Collagen, Citric Acid, Benzyl Alcohol (and) Methylchloroisothiazolinone (and) Methylisothiazolinone, Fragrance.

Section 51945-4

Aromatica Hair regenerator

Section 55105-1

Aromatica hair regenerator


Structured Label Content

Indications and Usage (34067-9)

Apply to wet hair, lather and rinse, repeat if necessary.

Dosage and Administration (34068-7)

Apply to wet hair, lather and rinse, repeat if necessary.

Warnings and Precautions (34071-1)

Avoid eye contact, if occurs rinse eyes thoroughly with water. If develop any allergic reaction, discontinue its use. Keep out reach of children. For external use only.

Section 50565-1 (50565-1)

Keep out reach of children. For external use only.

Section 50744-2 (50744-2)

Customer Service USA (917)508-6002

Customer Service RD (809)379-0900

www.mkcosmeticos.com

Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamide DEA, Betaine, Sodium Chloride, Propylene Glycol, Rosemary Extract, Hydrolyzed Collagen, Citric Acid, Benzyl Alcohol (and) Methylchloroisothiazolinone (and) Methylisothiazolinone, Fragrance.

Section 51945-4 (51945-4)

Aromatica Hair regenerator

Section 55105-1 (55105-1)

Aromatica hair regenerator


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)