Fb-009

Fb-009
SPL v2
SPL
SPL Set ID 0bc2d035-c588-4539-e063-6394a90a4228
Route
TOPICAL
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Amino Acids, Hair Keratin Butanediol (mixed Isomers) Caffeine Cocamidopropyl Betaine Biotin Glycerin Niacinamide Water 1,2-hexanediol Asian Ginseng Ethylhexylglycerin Amino Acids, Silk Allantoin 2,3,5,4'-tetrahydroxystilbene-2-o-.beta.-d-glucoside

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-07
Description

Minoxidil 5%

Medication Information

Warnings and Precautions

Use extreme caution and an eyebrow brush when applying over your eyebrows. If it comes into contact with your eyes, rinse thoroughly with plenty of water.

Don't use it on your eyelashes.

Indications and Usage

Prevent and Stop Hair Loss; Stimulate Hair Growth; Improve Fullness of Hair; Restore Vitality of Hair; Strengthen and Activate Hair Follicles.

Dosage and Administration

Apply 1 mL twice a day. Once in the morning and another time in the evening before bed. Use only on fully dry hair. Apply directly on top of the scalp of hair loss area.

Use Follixil every Morning and Night for a minimum of 3 months.

Description

Minoxidil 5%

Section 44425-7

Store it at room temperature between 20℃ to 25℃ (68℉ to 77℉). It should be kept in a tightly closed container away from light, heat, moisture, and children.

Section 50565-1

It should be kept in a tightly closed container away from light, heat, moisture, and children.

Section 50566-9

If you experience any issues or side effects, such as irritation, headaches, swelling, dandruff, or itchiness, please contact us at [email protected] for a professional consultation.

Section 50567-7

Use extreme caution and an eyebrow brush when applying over your eyebrows. If it comes into contact with your eyes, rinse thoroughly with plenty of water.

Don't use it on your eyelashes.

Section 50570-1

Don't use Follixil if you are:

  • Pregnant.
  • Breastfeeding.
  • Having heart sensitivity.
  • Super-sensitive skin.
  • Having open wounds.
  • Unexcited to boost your follicles and achieve bushy hair!
  • Planning to do physical activities in the next hour.
Section 51727-6

Aqua (Water), Butylene Glycol, Cocami Dopropyl Bataine, Keratin Amino Acids, Biotin, Glycerin, Polygonum Multiflorum Extract, Capryloyl Silk Amimo Acid, Allantion, Ginseng Extract, 1,2-Hexanediol, Ethylhexylglycerin, Niacinamide, Caffeine

Section 51945-4

Section 55105-1

Help hair and beard growth

Section 55106-9

Minoxidil 5%

Structured Label Content

Indications and Usage (34067-9)

Prevent and Stop Hair Loss; Stimulate Hair Growth; Improve Fullness of Hair; Restore Vitality of Hair; Strengthen and Activate Hair Follicles.

Dosage and Administration (34068-7)

Apply 1 mL twice a day. Once in the morning and another time in the evening before bed. Use only on fully dry hair. Apply directly on top of the scalp of hair loss area.

Use Follixil every Morning and Night for a minimum of 3 months.

Warnings and Precautions (34071-1)

Use extreme caution and an eyebrow brush when applying over your eyebrows. If it comes into contact with your eyes, rinse thoroughly with plenty of water.

Don't use it on your eyelashes.

Section 44425-7 (44425-7)

Store it at room temperature between 20℃ to 25℃ (68℉ to 77℉). It should be kept in a tightly closed container away from light, heat, moisture, and children.

Section 50565-1 (50565-1)

It should be kept in a tightly closed container away from light, heat, moisture, and children.

Section 50566-9 (50566-9)

If you experience any issues or side effects, such as irritation, headaches, swelling, dandruff, or itchiness, please contact us at [email protected] for a professional consultation.

Section 50567-7 (50567-7)

Use extreme caution and an eyebrow brush when applying over your eyebrows. If it comes into contact with your eyes, rinse thoroughly with plenty of water.

Don't use it on your eyelashes.

Section 50570-1 (50570-1)

Don't use Follixil if you are:

  • Pregnant.
  • Breastfeeding.
  • Having heart sensitivity.
  • Super-sensitive skin.
  • Having open wounds.
  • Unexcited to boost your follicles and achieve bushy hair!
  • Planning to do physical activities in the next hour.
Section 51727-6 (51727-6)

Aqua (Water), Butylene Glycol, Cocami Dopropyl Bataine, Keratin Amino Acids, Biotin, Glycerin, Polygonum Multiflorum Extract, Capryloyl Silk Amimo Acid, Allantion, Ginseng Extract, 1,2-Hexanediol, Ethylhexylglycerin, Niacinamide, Caffeine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Help hair and beard growth

Section 55106-9 (55106-9)

Minoxidil 5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:35.412480 · Updated: 2026-03-14T23:02:13.859151