SPL v3
SPL
SPL Set ID 263457cc-35ff-62fb-e063-6394a90a94da
Route
TOPICAL
Published
Effective Date 2024-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (74 mL)
Inactive Ingredients
Grapefruit Peel Vaccinium Myrtillus Whole Humulus Lupulus Whole Rosmarinus Officinalis Whole .alpha.-tocopherol Acetate Aloe Vera Leaf Chamomile Orange Peel Water Glycerin Cymbopogon Schoenanthus Whole Equisetum Arvense Whole Salvia Sclarea Whole Yucca Schidigera Lemon Peel Lavender Oil Althaea Officinalis Root Centella Asiatica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-02

Description

Ethyl Alcohol 74% V/V


Medication Information

Indications and Usage
  • For hand washing to decrease bacteria on the skin
  • recommended for repeated use throughout the day
Description

Ethyl Alcohol 74% V/V

Pupose

ANTISEPTIC

Warnings

For external use only

Flammable. Keep away from fire or flame.

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

Stop use and contact a doctor if irritation or redness develop or lasts for more than 72 hours.

Directions

• wet hands thoroughly with product - • allow to dry without wiping - • supervise children under 6 years old - • not recommended for infants

Active Ingredient

Ethyl Alcohol 74% V/V

Other Information

• may discolor certain fabrics - • store at room temperature 20°-25°C (66°-77°F).

Inactive Ingredients

Water, Glycerin, Lavendula Angustifolia (Lavender) Oil, Tocopheryl Acetate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cymbopogon Schoenanthus Leaf/Stem Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Sclarea (Clary) Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Yucca Schidigera Leaf/Root/Stem Extract.

Principal Display Panel

NDC 15127-008-02

Keep Out of Reach of Children

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


Structured Label Content

Pupose (PUPOSE)

ANTISEPTIC

Indications and Usage (34067-9)
  • For hand washing to decrease bacteria on the skin
  • recommended for repeated use throughout the day
Warnings (WARNINGS)

For external use only

Flammable. Keep away from fire or flame.

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

Stop use and contact a doctor if irritation or redness develop or lasts for more than 72 hours.

Directions (DIRECTIONS)

• wet hands thoroughly with product - • allow to dry without wiping - • supervise children under 6 years old - • not recommended for infants

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 74% V/V

Other Information (OTHER INFORMATION)

• may discolor certain fabrics - • store at room temperature 20°-25°C (66°-77°F).

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Lavendula Angustifolia (Lavender) Oil, Tocopheryl Acetate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cymbopogon Schoenanthus Leaf/Stem Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Sclarea (Clary) Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Yucca Schidigera Leaf/Root/Stem Extract.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 15127-008-02

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)