SPL v3
SPL
SPL Set ID 7b9adc93-0d15-48d5-90f4-462d95643349
Route
TOPICAL
Published
Effective Date 2019-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tranexamic Acid (0.02 g) Adenosine (0.004 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-12-01

Description

Active ingredients: Tranexamic acid 0.2%, Adenosine 0.04%

Purpose

Purpose: Anti wrinkle


Medication Information

Purpose

Purpose: Anti wrinkle

Description

Active ingredients: Tranexamic acid 0.2%, Adenosine 0.04%

Uses

Uses: For anti-wrinkle

Warnings

Warnings:

1. Discontinue use if the following symptoms occur. If symptoms are extreme consult a dermatologist. 1) Symptoms such as red dots, swollenness, itching, stimulation during use. 2) Symptoms such as the ones mentioned in 1) occur on the applied area. 2. Do not apply to parts of the skin that have rashes, are cut, or are infected. 3. Directions for storage and handling. 1) The lid must be closed after use. 2) Keep out of reach of babies and children. 3) Store in a cool and dry place and avoid exposure to direct sunlight.

Directions

Directions: Apply two times at morning and night onto the skin daily.

Active Ingredient

Active ingredients: Tranexamic acid 0.2%, Adenosine 0.04%

Inactive Ingredient

Inactive ingredients:

Water, Butylene Glycol, Glycerin, Octyldodecyl Myristate, Hydrogenated Poly(C6-14 Olefin), Limnanthes Alba (Meadowfoam) Seed Oil, Mineral Oil, Borago Officinalis Seed Oil, Rhodiola Sacra Root Extract, Cordyceps Sinensis Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxypropyl Bispalmitamide MEA, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Cyclopentasiloxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Arginine, Cyclohexasiloxane, Dextrin, Lecithin, Caprylyl Glycol, Tocopheryl Acetate,4-Butylresorcinol, Squalane, Trehalose, Phytosphingosine, Polysorbate 80, Sodium Hyaluronate, Sorbitan Oleate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

Keep Out of Reach of Children

Keep out of reach of babies and children.

Package Label.principal Display Panel


Structured Label Content

Uses

Uses: For anti-wrinkle

Purpose (PURPOSE)

Purpose: Anti wrinkle

Warnings (WARNINGS)

Warnings:

1. Discontinue use if the following symptoms occur. If symptoms are extreme consult a dermatologist. 1) Symptoms such as red dots, swollenness, itching, stimulation during use. 2) Symptoms such as the ones mentioned in 1) occur on the applied area. 2. Do not apply to parts of the skin that have rashes, are cut, or are infected. 3. Directions for storage and handling. 1) The lid must be closed after use. 2) Keep out of reach of babies and children. 3) Store in a cool and dry place and avoid exposure to direct sunlight.

Directions

Directions: Apply two times at morning and night onto the skin daily.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Tranexamic acid 0.2%, Adenosine 0.04%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Butylene Glycol, Glycerin, Octyldodecyl Myristate, Hydrogenated Poly(C6-14 Olefin), Limnanthes Alba (Meadowfoam) Seed Oil, Mineral Oil, Borago Officinalis Seed Oil, Rhodiola Sacra Root Extract, Cordyceps Sinensis Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxypropyl Bispalmitamide MEA, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Cyclopentasiloxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Arginine, Cyclohexasiloxane, Dextrin, Lecithin, Caprylyl Glycol, Tocopheryl Acetate,4-Butylresorcinol, Squalane, Trehalose, Phytosphingosine, Polysorbate 80, Sodium Hyaluronate, Sorbitan Oleate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

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

Keep out of reach of babies and children.

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


Advanced Ingredient Data


Raw Label Data

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