SPL v1
SPL
SPL Set ID f87e475a-58c3-442c-b898-f5be32d16e3e
Route
TOPICAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (35 mL)
Inactive Ingredients
Water Glycerin Glycyrrhizinate Dipotassium Green Tea Leaf Aloe Vera Leaf Hyaluronate Sodium Panthenol .alpha.-tocopherol Acetate Carbomer Homopolymer, Unspecified Type Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

ALCOHOL 70%

Purpose

SANITIZER


Medication Information

Purpose

SANITIZER

Description

ALCOHOL 70%

Uses

Disinfection of hands and skin

Warnings

1.Do not use the product on the following areas:

Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.

1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema

2)Skin irritation symptoms

3.Other precautions

1) For external use only (do not swallow).

2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.

3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).

(Limited to ethanol-containing products)

4) If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.

5) Do not use sealed bandages, cast bandages, or packs as they may cause irritation.

6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.

7) Use only for the intended purposes.

4.Precautions for storage

1) Keep away from direct sunlight and do not expose the product to heating devices or flame.

2) Keep out of reach of children and go to the hospital immediately if swallowed.

3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.

4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Dust or foreign substances may get on the product while using it.

Directions

Take an appropriate amount on your hands and rub thoroughly to dry.

Active Ingredient

ALCOHOL 70%

Inactive Ingredients

Water, Glycerin, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Sodium Hyaluronate, DL-Panthenol, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol

Keep Out of Reach of Children

Keep out of reach of children and go to the hospital immediately if swallowed.

Package Label.principal Display Panel


Structured Label Content

Uses

Disinfection of hands and skin

Purpose (PURPOSE)

SANITIZER

Warnings (WARNINGS)

1.Do not use the product on the following areas:

Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.

1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema

2)Skin irritation symptoms

3.Other precautions

1) For external use only (do not swallow).

2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.

3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).

(Limited to ethanol-containing products)

4) If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.

5) Do not use sealed bandages, cast bandages, or packs as they may cause irritation.

6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.

7) Use only for the intended purposes.

4.Precautions for storage

1) Keep away from direct sunlight and do not expose the product to heating devices or flame.

2) Keep out of reach of children and go to the hospital immediately if swallowed.

3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.

4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Dust or foreign substances may get on the product while using it.

Directions

Take an appropriate amount on your hands and rub thoroughly to dry.

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 70%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Sodium Hyaluronate, DL-Panthenol, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol

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

Keep out of reach of children and go to the hospital immediately if swallowed.

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


Advanced Ingredient Data


Raw Label Data

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