SPL v3
SPL
SPL Set ID 480b8c54-ee98-4768-bc90-8638b4825f23
Route
TOPICAL
Published
Effective Date 2020-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) .alpha.-tocopherol Acetate, Dl- Glycerin Isopropyl Alcohol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-24

Description

Ethyl alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70% v/v.

Use

Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

Section 50565-1

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

Warnings

For external use only.

Flammable. Keep away from open flames and sources of heat.

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

Directions

Place product in your palm to thoroughly cover your hand. Rub hands together briskly until dry.

For occasional and personal domestic use.

Supervise children under 6 years of age when using this product.

Active Ingredient

Ethyl alcohol 70% v/v.

Other Information

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F).

May discolor certain fabrics or surfaces.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, dl-alpa Tocopheryl Acetate, Glycerin, lsopropyl Alcohol, Triethanolamine, Water/Aqua/Eau



Questions? 1-800-221-9489

Package Label Principal Display Panel


Structured Label Content

Use

Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

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

Warnings

For external use only.

Flammable. Keep away from open flames and sources of heat.

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

Directions

Place product in your palm to thoroughly cover your hand. Rub hands together briskly until dry.

For occasional and personal domestic use.

Supervise children under 6 years of age when using this product.

Active Ingredient

Ethyl alcohol 70% v/v.

Other Information (Other information)

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F).

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Carbomer, dl-alpa Tocopheryl Acetate, Glycerin, lsopropyl Alcohol, Triethanolamine, Water/Aqua/Eau



Questions? 1-800-221-9489

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


Advanced Ingredient Data


Raw Label Data

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