SPL v2
SPL
SPL Set ID 1bb386d2-70c6-c487-e063-6294a90a19da
Route
TOPICAL
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Rosemary
Inactive Ingredients
Propylene Glycol Water Hydroxyacetophenone Peg-40 Castor Oil Butylene Glycol Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-29 Until 2027-01-15

Description

5% Minoxidil.........Hair regrowth treatment 5% Rosemary...........Anti-hair loss


Medication Information

Description

Use: To regrow hair of scalp and beard

Section 51945-4

84454-001-01, 84454-001-02, 84454-001-06

Warnings:
  • For external use only. Avoild contact with eyes. Please keep it out of reach of children.
  • Store at controlled room temperature 66°-77°F (20°-25℃).
How to Use

1. Apply 1ml with dropper 2 times a day directly onto the scalp in the hair loss area.

2. Use fingertips to massage solution into skin/hair for 2-3 minutes.

3. Using more or more often will not improve results.

Do Not Use If:
  • 5% Minoxidil topical solution is not intended for frontal baldness or receding hairline.
  • You have family history of hair loss.
  • Your hair loss is sudden and/or patchy
  • You are under 18 yearrs of age.Do not use on babies and children.
  • Your scalp is red, inflamed, infected, irritated, or painful
  • You use other medicines on the scalp.
Active Ingredient

5% Minoxidil.........Hair regrowth treatment

5% Rosemary...........Anti-hair loss

Inactive Ingredient

Water, Propylene Glycol, Butylene Glycol, Panthenol, Whitegrass Leaf/Root Extract, Dandelion Leaf Extract, Hawthorn Extract, Hydroxyacetophenone, 1.2-Hexanediol Sodium Edta, Peg-40 Hydrogenated Castor Oil, Fragrance

Dosage & Administration

Apply 1 ml with dropper 2 times a day.

When Using This Product:
  • It 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 regroth is different for each person.
Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Section 51945-4 (51945-4)

84454-001-01, 84454-001-02, 84454-001-06

Warnings: (WARNINGS:)
  • For external use only. Avoild contact with eyes. Please keep it out of reach of children.
  • Store at controlled room temperature 66°-77°F (20°-25℃).
How to Use (HOW TO USE)

1. Apply 1ml with dropper 2 times a day directly onto the scalp in the hair loss area.

2. Use fingertips to massage solution into skin/hair for 2-3 minutes.

3. Using more or more often will not improve results.

Description (DESCRIPTION)

Use: To regrow hair of scalp and beard

Do Not Use If: (DO NOT USE IF:)
  • 5% Minoxidil topical solution is not intended for frontal baldness or receding hairline.
  • You have family history of hair loss.
  • Your hair loss is sudden and/or patchy
  • You are under 18 yearrs of age.Do not use on babies and children.
  • Your scalp is red, inflamed, infected, irritated, or painful
  • You use other medicines on the scalp.
Active Ingredient (ACTIVE INGREDIENT)

5% Minoxidil.........Hair regrowth treatment

5% Rosemary...........Anti-hair loss

Inactive Ingredient (INACTIVE INGREDIENT)

Water, Propylene Glycol, Butylene Glycol, Panthenol, Whitegrass Leaf/Root Extract, Dandelion Leaf Extract, Hawthorn Extract, Hydroxyacetophenone, 1.2-Hexanediol Sodium Edta, Peg-40 Hydrogenated Castor Oil, Fragrance

Dosage & Administration (DOSAGE & ADMINISTRATION)

Apply 1 ml with dropper 2 times a day.

When Using This Product: (WHEN USING THIS PRODUCT:)
  • It 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 regroth is different for each person.
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)