SPL v1
SPL
SPL Set ID 33d3abb1-1483-2f5b-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-05-26
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 2016-05-25

Description

Active Ingredient: Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings: For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes. Do not use in ears or mouth. When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Indications and Usage

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

Dosage and Administration

Directions: Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

Description

Active Ingredient: Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 51727-6

Inactive ingredients: Water, Aloe Barbadenis Leaf, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

Section 51945-4

Section 55105-1

Purpose Antiseptic

Section 55106-9

Active Ingredient: Ethyl Alcohol 62%

Other Information

Do not store in temperature over 118 F.


Structured Label Content

Indications and Usage (34067-9)

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

Dosage and Administration (34068-7)

Directions: Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

Warnings and Precautions (34071-1)

Warnings: For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes. Do not use in ears or mouth. When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 51727-6 (51727-6)

Inactive ingredients: Water, Aloe Barbadenis Leaf, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Ethyl Alcohol 62%

Other Information (Other information)

Do not store in temperature over 118 F.


Advanced Ingredient Data


Raw Label Data

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