SPL v2
SPL
SPL Set ID a5a83ecc-f187-b318-e053-2995a90a1f98
Route
TOPICAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Lavender Oil Carbomer Homopolymer, Unspecified Type Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

To decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1

Keep out of reach for children.

Section 50566-9

Stop use and ask doctor if irritation or rash appears and lasts.

Section 50567-7

Do not use in or around the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts. Keep out of reach for children.

Warnings

Keep away from fire or flame.

For external use only: Hands

Directions

1, Place enough product in you palm to thoroughly spread on both hands and rub into the skin until dry.

2, Children under 6 years of age should be supervised when using this product.

Do Not Use

Do not use in or around the eyes. In case of contact, rinse eyes thoroughly with water.

Package Label

Other Information

1, Store below 106F(41°C).

2, May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Water,Carbomer,Triethanolamine,Lavander oil


Structured Label Content

Use

To decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach for children.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

Do not use in or around the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts. Keep out of reach for children.

Purpose

Antiseptic

Warnings

Keep away from fire or flame.

For external use only: Hands

Directions

1, Place enough product in you palm to thoroughly spread on both hands and rub into the skin until dry.

2, Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)

Do not use in or around the eyes. In case of contact, rinse eyes thoroughly with water.

Package Label (package label)

Other Information (Other information)

1, Store below 106F(41°C).

2, May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water,Carbomer,Triethanolamine,Lavander oil


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)