811f4b63-48cc-44c8-880d-3379f68bd441

SPL v1
SPL
SPL Set ID 811f4b63-48cc-44c8-880d-3379f68bd441
Route
topical
Published
Effective Date 2017-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
adenosine (0.002 g)
Inactive Ingredients
water butylene glycol

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2017-06-01

Purpose

Purpose: SKIN PROTECTANT

Description

Active ingredients: Adenosine 0.04%


Medication Information

Purpose

Purpose: SKIN PROTECTANT

Description

Active ingredients: Adenosine 0.04%

Active Ingredient

Active ingredients: Adenosine 0.04%

Precautions On Use

Precautions on use: 1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms. A) If there are red spots, swelling, itchiness, or irritation B) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight. 2. Precautions on storage and handling. A) Make sure to close the cap after use. B) Keep out of the reach of children. C) Do not keep the product in a hot or cold place or a place getting direct sunlight. 3. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

Inactive Ingredient

Inactive ingredients:

SP F I) Water, illite Extract, Carbomer, Butylene Glycol, Caffeine, Phenoxyethanol, Carprylyl Glycol, Glycerin, 1,2-Hexanediol, Avena Sativa (Oat) Kernel Extract, Beta-Glucan, Acetyl Hexapeptide-8, Copper Tripeptide-1, Diospyros Kaki Leaf Extract, Centella Asiatica Extract, Theobroma Cacao Extract, Chamomilla Recutita (Matricaria) Extract, Wine Extract, Ethylhexylglycerin, Hovenia Dulcis Fruit Extract, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Seed Extract, Origanum Vulgare Flower Extract, Scutellaria Baicalensis Root Extract, Sophora Flavescens Root Extract

SP F II) Water, illite Extract, Sodium Silicate, Butylene Glycol, Hydroxypropyl Chitosan, Glycerin, 1,2-Hexanediol, Phenoxyethanol, Citric acid, Polyepsilon-Lysine, Alcohol, Paeonia Albiflora Flower Extract, Ipomoea Purpurea Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Portulaca Oleracea Extract, Camellia Sinensis Leaf Extract

Volume) SP F I: 6mL, SP F II: 1mL

Indications & Usage

Suggested use and application order:

1. Open SP F Ⅰ until the dotted line. (try not to spill the liquid content inside) 2. Open SP F Ⅱ and mix with SP F Ⅰ. (try not to spill the liquid content inside) 3. Seal the package of SP F Ⅰ and strongly shake the package more than 10 times to mix two agents well. (turning into gel when mixed enough) 4. Apply the content over your face enough with a brush contained inside the package. 5. Regardless of individual difference, wait for 15 ~ 20 minutes. (gently fan yourself while waiting) Try not to move or speak. 6. For the first few times, your skin may feel strongly stretched and there is a difference in color change depending on area. (discharge of toxin out of the skin) Feeling of stretching may differ by individual skin condition. 7. After using wash your face with warm water and then use soap to cleanse your face once again. 8. Dry your face with a dry towel.

*Use up a single package at a time.

Dosage & Administration

Suggested use and application order:

1. Open SP F Ⅰ until the dotted line. (try not to spill the liquid content inside) 2. Open SP F Ⅱ and mix with SP F Ⅰ. (try not to spill the liquid content inside) 3. Seal the package of SP F Ⅰ and strongly shake the package more than 10 times to mix two agents well. (turning into gel when mixed enough) 4. Apply the content over your face enough with a brush contained inside the package. 5. Regardless of individual difference, wait for 15 ~ 20 minutes. (gently fan yourself while waiting) Try not to move or speak. 6. For the first few times, your skin may feel strongly stretched and there is a difference in color change depending on area. (discharge of toxin out of the skin) Feeling of stretching may differ by individual skin condition. 7. After using wash your face with warm water and then use soap to cleanse your face once again. 8. Dry your face with a dry towel.

*Use up a single package at a time.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: SKIN PROTECTANT

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Adenosine 0.04%

Precautions On Use (Precautions on use)

Precautions on use: 1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms. A) If there are red spots, swelling, itchiness, or irritation B) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight. 2. Precautions on storage and handling. A) Make sure to close the cap after use. B) Keep out of the reach of children. C) Do not keep the product in a hot or cold place or a place getting direct sunlight. 3. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

SP F I) Water, illite Extract, Carbomer, Butylene Glycol, Caffeine, Phenoxyethanol, Carprylyl Glycol, Glycerin, 1,2-Hexanediol, Avena Sativa (Oat) Kernel Extract, Beta-Glucan, Acetyl Hexapeptide-8, Copper Tripeptide-1, Diospyros Kaki Leaf Extract, Centella Asiatica Extract, Theobroma Cacao Extract, Chamomilla Recutita (Matricaria) Extract, Wine Extract, Ethylhexylglycerin, Hovenia Dulcis Fruit Extract, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Seed Extract, Origanum Vulgare Flower Extract, Scutellaria Baicalensis Root Extract, Sophora Flavescens Root Extract

SP F II) Water, illite Extract, Sodium Silicate, Butylene Glycol, Hydroxypropyl Chitosan, Glycerin, 1,2-Hexanediol, Phenoxyethanol, Citric acid, Polyepsilon-Lysine, Alcohol, Paeonia Albiflora Flower Extract, Ipomoea Purpurea Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Portulaca Oleracea Extract, Camellia Sinensis Leaf Extract

Volume) SP F I: 6mL, SP F II: 1mL

Indications & Usage (INDICATIONS & USAGE)

Suggested use and application order:

1. Open SP F Ⅰ until the dotted line. (try not to spill the liquid content inside) 2. Open SP F Ⅱ and mix with SP F Ⅰ. (try not to spill the liquid content inside) 3. Seal the package of SP F Ⅰ and strongly shake the package more than 10 times to mix two agents well. (turning into gel when mixed enough) 4. Apply the content over your face enough with a brush contained inside the package. 5. Regardless of individual difference, wait for 15 ~ 20 minutes. (gently fan yourself while waiting) Try not to move or speak. 6. For the first few times, your skin may feel strongly stretched and there is a difference in color change depending on area. (discharge of toxin out of the skin) Feeling of stretching may differ by individual skin condition. 7. After using wash your face with warm water and then use soap to cleanse your face once again. 8. Dry your face with a dry towel.

*Use up a single package at a time.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Suggested use and application order:

1. Open SP F Ⅰ until the dotted line. (try not to spill the liquid content inside) 2. Open SP F Ⅱ and mix with SP F Ⅰ. (try not to spill the liquid content inside) 3. Seal the package of SP F Ⅰ and strongly shake the package more than 10 times to mix two agents well. (turning into gel when mixed enough) 4. Apply the content over your face enough with a brush contained inside the package. 5. Regardless of individual difference, wait for 15 ~ 20 minutes. (gently fan yourself while waiting) Try not to move or speak. 6. For the first few times, your skin may feel strongly stretched and there is a difference in color change depending on area. (discharge of toxin out of the skin) Feeling of stretching may differ by individual skin condition. 7. After using wash your face with warm water and then use soap to cleanse your face once again. 8. Dry your face with a dry towel.

*Use up a single package at a time.

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

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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