SPL v1
SPL
SPL Set ID 0b631789-b98e-46c0-be76-2c2bf148f3fb
Route
TOPICAL
Published
Effective Date 2020-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-09

Description

Ethyl Alcohol 70% v/v.

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v.

Use

Hand sanitizer to help reduce bacteria on the skin.

Section 50565-1

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

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

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

Directions

Wet hands thoroughly with product and allow to dry.

Children under 6 years of age should be supervised when using product.

Other information

Store below 110° F (43° C). May discolor certain fabrics or surfaces.

Active Ingredient

Ethyl Alcohol 70% v/v.

Inactive Ingredients

Purified Water (Aqua), Glycerin, Acrylates Copolymer, Tocopherol Acetate, Triethanolamine, Fragrance (Parfum)

Package Label Principal Display Panel


Structured Label Content

Use

Hand sanitizer to help reduce bacteria on the skin.

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

Antimicrobial

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.

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

Directions

Wet hands thoroughly with product and allow to dry.

Children under 6 years of age should be supervised when using product.

Other information

Store below 110° F (43° C). May discolor certain fabrics or surfaces.

Active Ingredient

Ethyl Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

Purified Water (Aqua), Glycerin, Acrylates Copolymer, Tocopherol Acetate, Triethanolamine, Fragrance (Parfum)

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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