SPL v1
SPL
SPL Set ID 5ce721cf-47b8-3cac-e053-2a91aa0adf13
Route
TOPICAL
Published
Effective Date 2017-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-11-01

Description

Active Ingredient: Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Indications and Usage

Uses

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

Dosage and Administration

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6 use only under adult supervision. Not recommended for infants.

Description

Active Ingredient: Ethyl Alcohol 62%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash develops and continues for more that 72 hours.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanoamine

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient:

Ethyl Alcohol 62%

Section 60561-8

Other Information

Do not store above 105F. May discolor some fabrics. Harmful to wood finishes and plastics


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6 use only under adult supervision. Not recommended for infants.

Warnings and Precautions (34071-1)

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash develops and continues for more that 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanoamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient:

Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Other Information

Do not store above 105F. May discolor some fabrics. Harmful to wood finishes and plastics


Advanced Ingredient Data


Raw Label Data

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