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SPL v1
SPL
SPL Set ID 9d1b926e-ba75-4d28-838e-ec40b1fee2d5
Route
TOPICAL
Published
Effective Date 2020-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 L)
Inactive Ingredients
Water Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Trolamine .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-30

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Uses:

​To decrease bacteria on the skin that could cause disease - Recommended for repeated use.

Section 42229-5

Distributed by Imperial Dade

Manufactured for Imperial Dade

www.imperialdade.com

255 Route 1 & 9

Jersey City, NJ 07306.

MADE IN USA

Section 50565-1

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

Packaging

Warnings:

For external use only: Hands.

FLAMMABLE, KEEP AWAY FROM FIRE OR 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 and redness develop or condition persists for more than 72 hours.

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.

drug Facts

Active Ingredient

Ethyl Alcohol 70%

Other Information:

Do not store above 105°F ■ May discolor some fabrics

Harmful to wood finishes and plastics.

Inactive Ingredients

Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer, Triethanolamine, Vitamin E (Tocopheryl Acetate).


Structured Label Content

Uses:

​To decrease bacteria on the skin that could cause disease - Recommended for repeated use.

Section 42229-5 (42229-5)

Distributed by Imperial Dade

Manufactured for Imperial Dade

www.imperialdade.com

255 Route 1 & 9

Jersey City, NJ 07306.

MADE IN USA

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Packaging

Warnings: (WARNINGS:)

For external use only: Hands.

FLAMMABLE, KEEP AWAY FROM FIRE OR 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 and redness develop or condition persists for more than 72 hours.

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.

drug Facts (Drug Facts)

Active Ingredient (Active ingredient)

Ethyl Alcohol 70%

Other Information: (Other information:)

Do not store above 105°F ■ May discolor some fabrics

Harmful to wood finishes and plastics.

Inactive Ingredients (Inactive ingredients)

Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer, Triethanolamine, Vitamin E (Tocopheryl Acetate).


Advanced Ingredient Data


Raw Label Data

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