SPL v1
SPL
SPL Set ID 161c467e-ba2e-5404-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Interpolymer Type A (55000 Cps) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-05-15

Description

Active Ingredient: Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings:

Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

Indications and Usage

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and Administration

Directions:

Not recommended for infants. Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Description

Active Ingredient: Ethyl Alcohol 62%

Section 44425-7

Other Information:

Do not store above 110 F. May discolor some fabrics.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9

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

Section 50567-7

When using this product, do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Section 51727-6

Water, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Aloe barbadenis Leaf Juice, Fragrance

Section 51945-4

Section 55105-1

Purpose:

Antiseptic

Section 55106-9

Active Ingredient:

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and Administration (34068-7)

Directions:

Not recommended for infants. Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Warnings and Precautions (34071-1)

Warnings:

Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

Section 44425-7 (44425-7)

Other Information:

Do not store above 110 F. May discolor some fabrics.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product, do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Water, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Aloe barbadenis Leaf Juice, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient:

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)