SPL v1
SPL
SPL Set ID 711ed56a-4d5a-4ecd-ba53-17953ba49b65
Route
TOPICAL
Published
Effective Date 2020-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (21 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Aminomethylpropanol Aloe Vera Leaf Citrus Paradisi Seed Butylene Glycol Edetate Disodium Anhydrous Centella Asiatica Whole Jojoba Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethyl Alcohol 70.0%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70.0%

Uses

■ to decrease bacteria on the skin that could cause disease

■ recommended for repeated use

Warnings

For external use only-hands

Flammable. Keep away from heat and flame.

When using this product ■ Keep out of eyes. In case of contact with eyes,

flush thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.

Stop use and ask a doctor if

■irritation or redness develops

■condition persists for more than 72 hours

Questions

www thecremeshop.com

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

Active Ingredient

Ethyl Alcohol 70.0%

Other Information

■ do not store above 110F(40C)

■ may discolor some fabrics

■ harmful to wood finishes and plastics

Inactive Ingredients

Water(Aqua), Carbomer, Aminomethyl Propanol, Aloe Vera Gel, Grapefruit Seed Extract, Butylene Glycol, Disodium EDTA, Centella Asiatica Extract, Jojoba Oil, Tocopherol, Fragrance

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center.

Package Label.principal Display Panel


Structured Label Content

Uses

■ to decrease bacteria on the skin that could cause disease

■ recommended for repeated use

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only-hands

Flammable. Keep away from heat and flame.

When using this product ■ Keep out of eyes. In case of contact with eyes,

flush thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.

Stop use and ask a doctor if

■irritation or redness develops

■condition persists for more than 72 hours

Questions (QUESTIONS)

www thecremeshop.com

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

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70.0%

Other Information

■ do not store above 110F(40C)

■ may discolor some fabrics

■ harmful to wood finishes and plastics

Inactive Ingredients (INACTIVE INGREDIENTS)

Water(Aqua), Carbomer, Aminomethyl Propanol, Aloe Vera Gel, Grapefruit Seed Extract, Butylene Glycol, Disodium EDTA, Centella Asiatica Extract, Jojoba Oil, Tocopherol, Fragrance

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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