SPL v1
SPL
SPL Set ID 4d018cb4-1d39-48f5-95b1-eb0f510bbe29
Route
TOPICAL
Published
Effective Date 2020-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacinamide (0.06 g)
Inactive Ingredients
Water Panthenol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-02-01

Description

Active ingredients: Niacinamide 2.0%

Purpose

Purpose: Hair elasticity


Medication Information

Purpose

Purpose: Hair elasticity

Description

Active ingredients: Niacinamide 2.0%

Uses

Uses:

Improves effects of hair elasticity.

Warnings

Warnings:

For external use only

1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product

2. Do not apply to open wounds.

3. Avoid contact with eyes.

Storage and handling

4. Replace the cap after use

5. Keep out of reach of children.

6. Avoid direct sunlight.

Directions

Directions:

■ Put solvent into the powder ampoule and shake gently enough to dissolve the mixture.

■ Take proper amount and gently apply onto the scalp

Active Ingredient

Active ingredients: Niacinamide 2.0%

Inactive Ingredient

Inactive ingredients:



[Powder] HUMAN ADIPOSE DERIVED STEM CELL CONDITIONED MEDIA, Asparagus Officinalis Extract



[Solvent] Water, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Hyaluronate

Keep Out of Reach of Children Section

KEEP OUT OF REACH OF CHILDREN SECTION

Package Label.principal Display Panel


Structured Label Content

Uses

Uses:

Improves effects of hair elasticity.

Purpose (PURPOSE)

Purpose: Hair elasticity

Warnings (WARNINGS)

Warnings:

For external use only

1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product

2. Do not apply to open wounds.

3. Avoid contact with eyes.

Storage and handling

4. Replace the cap after use

5. Keep out of reach of children.

6. Avoid direct sunlight.

Directions

Directions:

■ Put solvent into the powder ampoule and shake gently enough to dissolve the mixture.

■ Take proper amount and gently apply onto the scalp

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Niacinamide 2.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:



[Powder] HUMAN ADIPOSE DERIVED STEM CELL CONDITIONED MEDIA, Asparagus Officinalis Extract



[Solvent] Water, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Hyaluronate

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

KEEP OUT OF REACH OF CHILDREN SECTION

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)