SPL v1
SPL
SPL Set ID a4f58d90-21d0-55f5-e053-2a95a90a4e66
Route
TOPICAL
Published
Effective Date 2020-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Butylene Glycol Geraniol Water 1,2-hexanediol

Identifiers & Packaging

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

Description

Antiseptic


Medication Information

Warnings and Precautions

.• Flammable. Keep away from fire or flame.

• For external use only.

• When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor if irritation or rash appears

and lasts.

• Keep Out of Reach of Children.

• Do not eat.

• If swallowed, get medical help or contact a Poison Control

Center right away

Indications and Usage

Directions

• Put enough product in your palm to cover hands and rub

hands together briskly until dry.

• Children under 6 years of age should be supervised when

using. Not recommended for infants.

Dosage and Administration

For the external use only

Description

Antiseptic

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, Porphyra 334, Porphyra Yezoensis Extract, Sophora Flavescens Extract, Rosa Damascena Callus Culture Extract, Glycine Max (Soybean) Phytoplacenta Extract, Diospyros Kaki Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Coffea Arabica (Coffee) Seed Extract, Carthamus Tinctorius (Safflower) Flower Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Piperitum Fruit Extract, Butylene Glycol, Limonene, 1,2

Hexanediol, Linalool, Citronellol, Alpha Isomethyl Ionone, Geraniol, Hydroxycitronellal, Hexyl Cinnamal, Fragrance

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

Directions

• Put enough product in your palm to cover hands and rub

hands together briskly until dry.

• Children under 6 years of age should be supervised when

using. Not recommended for infants.

Dosage and Administration (34068-7)

For the external use only

Warnings and Precautions (34071-1)

.• Flammable. Keep away from fire or flame.

• For external use only.

• When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor if irritation or rash appears

and lasts.

• Keep Out of Reach of Children.

• Do not eat.

• If swallowed, get medical help or contact a Poison Control

Center right away

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water, Porphyra 334, Porphyra Yezoensis Extract, Sophora Flavescens Extract, Rosa Damascena Callus Culture Extract, Glycine Max (Soybean) Phytoplacenta Extract, Diospyros Kaki Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Coffea Arabica (Coffee) Seed Extract, Carthamus Tinctorius (Safflower) Flower Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Piperitum Fruit Extract, Butylene Glycol, Limonene, 1,2

Hexanediol, Linalool, Citronellol, Alpha Isomethyl Ionone, Geraniol, Hydroxycitronellal, Hexyl Cinnamal, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)