SPL v1
SPL
SPL Set ID a97d0099-c8e0-37c7-e053-2995a90a8576
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Thyme Oil Water Orange Oil Glycerin .alpha.-tocopherol, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-10

Description

Ethanol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethanol 70%

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use

Section 44425-7

Store at room temperature 20-25 °C (66-77 °F)

Section 50565-1

-Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Section 50567-7

-For external use only.

Section 50569-3

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

Section 50570-1

-Do not use in eyes. If contact occurs, flush thoroughly with water

Section 51727-6

Inactive Ingredients: Aqua, Glycerin, Tocopherol.

Purpose:

Antiseptic

Warnings:

-Flammable, keep away from fire or flame.

Directions:

Wet hands thoroughly with product and allow to dry without wiping

-Do not use other than directed

Active Ingredients

Ethanol 70%

59.15 Ml Ndc: 79556 123 02


Structured Label Content

Uses:

-For hand washing to decrease bacteria on skin.

-Recommended for repeated use

Section 44425-7 (44425-7)

Store at room temperature 20-25 °C (66-77 °F)

Section 50565-1 (50565-1)

-Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Section 50567-7 (50567-7)

-For external use only.

Section 50569-3 (50569-3)

-Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

Section 50570-1 (50570-1)

-Do not use in eyes. If contact occurs, flush thoroughly with water

Section 51727-6 (51727-6)

Inactive Ingredients: Aqua, Glycerin, Tocopherol.

Purpose:

Antiseptic

Warnings: (WARNINGS:)

-Flammable, keep away from fire or flame.

Directions: (-Directions:)

Wet hands thoroughly with product and allow to dry without wiping

-Do not use other than directed

Active Ingredients

Ethanol 70%

59.15 Ml Ndc: 79556 123 02 (59.15 mL NDC: 79556-123-02)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)