409de2af-f6f6-8181-e063-6294a90a0b4b

SPL v1
SPL
SPL Set ID 409de2af-f6f6-8181-e063-6294a90a0b4b
Route
topical
Published
Effective Date 2025-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
biotin (5 g) tocopherol (3 g) minoxidil (8 g) alcohol (75.8 g) butylene glycol
Inactive Ingredients
panthenol caffeine mentha piperita (peppermint) oil rosmarinus officinalis (rosemary) leaf oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-08

Description

Active ingredientsButylene Glycol 75.8%,Alcohol 8%,Minoxidil 5%,Biotin 5%,Tocopherol 3%


Medication Information

Warnings and Precautions

Do not use if

Your hair loss is on the front of the scalp. Minoxidil topical solution5% is not intended for frontal baldness or receding hairlineYou have no family history of hair lossYour hair loss is sudden and/or patchye You do not know the reason for your hair lossYou are under 18 years of age. Do not use on babies and childrenYour scalp is red, infamed, infected, irritated, or painfulYou use other medicines on the scalp

Active Ingredient

Active ingredientsButylene Glycol 75.8%,Alcohol 8%,Minoxidil 5%,Biotin 5%,Tocopherol 3%

Indications and Usage

Do not apply on other parts of the body

Avoid contact with the eyes. In case of accidental contact, rinseeyes with large amounts of cool tap water.Some people have experienced changes in hair color and/or textureIt takes time to regrow hair. Results may occur at 2 months withtwice a day usage. For some men, you may need to use thisproduct for at least 4 months before you see results.

The amount of hair regrowth is different for each person. Thisproduct will not work for all people.

Dosage and Administration

Apply 1 ML(few drops) directly onto scalp on the hairloss areaUse fingertips to massage solution into skin!hair for2-3 minuteseAllow time for hair tofully absorb growth serum For bestresults, usetwice daily on clean dry hair

Description

Active ingredientsButylene Glycol 75.8%,Alcohol 8%,Minoxidil 5%,Biotin 5%,Tocopherol 3%

Section 50565-1

Keep out of Reach of children ,You are under 18 years of age. Do not use on babies and children

Section 51727-6

Panthenol, Caffeine, Rosmarinus Officinalis (Rosemary) Leaf Oil,Mentha Piperita (Peppermint) Oil

Section 51945-4

Section 55105-1

Hair regrowth treatment


Structured Label Content

Warnings and Precautions (34071-1)

Do not use if

Your hair loss is on the front of the scalp. Minoxidil topical solution5% is not intended for frontal baldness or receding hairlineYou have no family history of hair lossYour hair loss is sudden and/or patchye You do not know the reason for your hair lossYou are under 18 years of age. Do not use on babies and childrenYour scalp is red, infamed, infected, irritated, or painfulYou use other medicines on the scalp

Active Ingredient (55106-9)

Active ingredientsButylene Glycol 75.8%,Alcohol 8%,Minoxidil 5%,Biotin 5%,Tocopherol 3%

Indications and Usage (34067-9)

Do not apply on other parts of the body

Avoid contact with the eyes. In case of accidental contact, rinseeyes with large amounts of cool tap water.Some people have experienced changes in hair color and/or textureIt takes time to regrow hair. Results may occur at 2 months withtwice a day usage. For some men, you may need to use thisproduct for at least 4 months before you see results.

The amount of hair regrowth is different for each person. Thisproduct will not work for all people.

Dosage and Administration (34068-7)

Apply 1 ML(few drops) directly onto scalp on the hairloss areaUse fingertips to massage solution into skin!hair for2-3 minuteseAllow time for hair tofully absorb growth serum For bestresults, usetwice daily on clean dry hair

Section 50565-1 (50565-1)

Keep out of Reach of children ,You are under 18 years of age. Do not use on babies and children

Section 51727-6 (51727-6)

Panthenol, Caffeine, Rosmarinus Officinalis (Rosemary) Leaf Oil,Mentha Piperita (Peppermint) Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment


Advanced Ingredient Data


Raw Label Data

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