SPL v1
SPL
SPL Set ID 367ea6b4-64f1-c515-e063-6294a90a9e4e
Route
TOPICAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Platycladus Orientalis Leaf (0.05 g)
Inactive Ingredients
Aqua Fragrance 13576 Ginger Cocamide Dea Cocamidopropyl Betaine Sodium Laureth Sulfate Citric Acid Asian Ginseng Sodium Chloride Edetate Disodium Dmdm Hydantoin Simmondsia Chinensis (jojoba) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

GINGER 0.05% – Boosts scalp microcirculation and stimulates hair follicles. PLATYCLADUS ORIENTALIS LEAF 0.03% – May help inhibit DHT activity and reduce hair follicle miniaturization. ASIAN GINSENG 0.05% – Supports natural hair regrowth and revitalizes dormant follicles.

Purpose

Hair loss prevention and hair regrowth support

Dosage and Administration

Frequency: Apply to wet scalp 3-5 times weekly. Adjust based on hair type: Oily scalp: Up to daily use. Dry/sensitive scalp: Reduce to 2-3 times weekly. ​Amount: Use 5-10 mL (approximately 1-2 teaspoonfuls) per application. ​Steps: Wet hair and scalp thoroughly with warm water. Gently massage shampoo into scalp for 3-5 minutes, focusing on thinning areas. Rinse completely. For deeper cleansing, repeat application once. Follow with conditioner if needed. Note: Allow 48 hours between uses if scalp sensitivity occurs.


Medication Information

Purpose

Hair loss prevention and hair regrowth support

Dosage and Administration

Frequency: Apply to wet scalp 3-5 times weekly. Adjust based on hair type:

Oily scalp: Up to daily use.

Dry/sensitive scalp: Reduce to 2-3 times weekly.

​Amount: Use 5-10 mL (approximately 1-2 teaspoonfuls) per application.

​Steps:

Wet hair and scalp thoroughly with warm water.

Gently massage shampoo into scalp for 3-5 minutes, focusing on thinning areas.

Rinse completely. For deeper cleansing, repeat application once.

Follow with conditioner if needed.

Note: Allow 48 hours between uses if scalp sensitivity occurs.

Description

GINGER 0.05% – Boosts scalp microcirculation and stimulates hair follicles. PLATYCLADUS ORIENTALIS LEAF 0.03% – May help inhibit DHT activity and reduce hair follicle miniaturization. ASIAN GINSENG 0.05% – Supports natural hair regrowth and revitalizes dormant follicles.

Uses

Helps reduce hair loss caused by various factors, including:

– Androgenetic alopecia (pattern hair loss)

– Postpartum hair shedding

– Stress-induced hair thinning

– Environmental damage

– Poor sleep or hormonal imbalance

Supports healthy scalp function and promotes natural hair regrowth.

Strengthens hair from the roots to reduce breakage and shedding.

Warnings

For external use only.

When using this product:

– Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

– Do not apply to broken or irritated scalp.

Stop use and ask a doctor if:

– Irritation, redness, or excessive dryness occurs.

– Condition worsens or does not improve after regular use.

Keep out of reach of children.

– If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use

Discontinue use and consult a healthcare provider if:

Scalp irritation, itching, or flaking persists for >72 hours after stopping the product.

You develop a rash, hives, swelling, or difficulty breathing (signs of allergic reaction).

Hair loss increases unexpectedly or new patches of hair loss appear.

You experience systemic symptoms (e.g., dizziness, nausea) possibly linked to accidental ingestion.

Do Not Use

Do NOT use this product if:

You are allergic to any ingredient listed under "Active Ingredients" or "Inactive Ingredients".

You are under 18 years old (safety not established in pediatric populations).

Your scalp has open wounds, burns, infections (e.g., psoriasis, severe dandruff), or active inflammation.

You are using prescription topical medications (e.g., corticosteroids, retinoids) unless directed by a doctor.

Active Ingredients

GINGER 0.05% – Boosts scalp microcirculation and stimulates hair follicles.

PLATYCLADUS ORIENTALIS LEAF 0.03% – May help inhibit DHT activity and reduce hair follicle miniaturization.

ASIAN GINSENG 0.05% – Supports natural hair regrowth and revitalizes dormant follicles.

When Using Section

Precautions during use:

Avoid mixing with other hair treatments (e.g., chemical dyes, perms) unless spaced by 24 hours.

Store at room temperature (15°C–30°C). Discard if product separates or changes color.

Wash hands immediately after application to prevent accidental transfer to face or eyes.

Temporary mild scalp warmth or tingling may occur due to active botanical extracts (e.g., ginger). If persistent, discontinue use.

Inactive Ingredients

Aqua , Sodium Laureth Sulfate, Cocamide DEA, Cocamidopropyl Betaine, Sodium Chloride, DMDM Hydantoin,FRAGRANCE 13576 , Citric Acid, EDETATE DISODIUM, Simmondsia Chinensis (Jojoba) Seed Oil

Principal Display Panel

Keep Out of Reach of Children.

Keep out of reach of children


Structured Label Content

Uses

Helps reduce hair loss caused by various factors, including:

– Androgenetic alopecia (pattern hair loss)

– Postpartum hair shedding

– Stress-induced hair thinning

– Environmental damage

– Poor sleep or hormonal imbalance

Supports healthy scalp function and promotes natural hair regrowth.

Strengthens hair from the roots to reduce breakage and shedding.

Purpose

Hair loss prevention and hair regrowth support

Warnings

For external use only.

When using this product:

– Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

– Do not apply to broken or irritated scalp.

Stop use and ask a doctor if:

– Irritation, redness, or excessive dryness occurs.

– Condition worsens or does not improve after regular use.

Keep out of reach of children.

– If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use (stop use)

Discontinue use and consult a healthcare provider if:

Scalp irritation, itching, or flaking persists for >72 hours after stopping the product.

You develop a rash, hives, swelling, or difficulty breathing (signs of allergic reaction).

Hair loss increases unexpectedly or new patches of hair loss appear.

You experience systemic symptoms (e.g., dizziness, nausea) possibly linked to accidental ingestion.

Do Not Use (Do not use)

Do NOT use this product if:

You are allergic to any ingredient listed under "Active Ingredients" or "Inactive Ingredients".

You are under 18 years old (safety not established in pediatric populations).

Your scalp has open wounds, burns, infections (e.g., psoriasis, severe dandruff), or active inflammation.

You are using prescription topical medications (e.g., corticosteroids, retinoids) unless directed by a doctor.

Active Ingredients (Active ingredients)

GINGER 0.05% – Boosts scalp microcirculation and stimulates hair follicles.

PLATYCLADUS ORIENTALIS LEAF 0.03% – May help inhibit DHT activity and reduce hair follicle miniaturization.

ASIAN GINSENG 0.05% – Supports natural hair regrowth and revitalizes dormant follicles.

When Using Section (When using section)

Precautions during use:

Avoid mixing with other hair treatments (e.g., chemical dyes, perms) unless spaced by 24 hours.

Store at room temperature (15°C–30°C). Discard if product separates or changes color.

Wash hands immediately after application to prevent accidental transfer to face or eyes.

Temporary mild scalp warmth or tingling may occur due to active botanical extracts (e.g., ginger). If persistent, discontinue use.

Inactive Ingredients (Inactive ingredients)

Aqua , Sodium Laureth Sulfate, Cocamide DEA, Cocamidopropyl Betaine, Sodium Chloride, DMDM Hydantoin,FRAGRANCE 13576 , Citric Acid, EDETATE DISODIUM, Simmondsia Chinensis (Jojoba) Seed Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (Dosage and administration)

Frequency: Apply to wet scalp 3-5 times weekly. Adjust based on hair type:

Oily scalp: Up to daily use.

Dry/sensitive scalp: Reduce to 2-3 times weekly.

​Amount: Use 5-10 mL (approximately 1-2 teaspoonfuls) per application.

​Steps:

Wet hair and scalp thoroughly with warm water.

Gently massage shampoo into scalp for 3-5 minutes, focusing on thinning areas.

Rinse completely. For deeper cleansing, repeat application once.

Follow with conditioner if needed.

Note: Allow 48 hours between uses if scalp sensitivity occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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