a95925df-bcf4-0306-e053-2a95a90accea

SPL v2
SPL
SPL Set ID a95925df-bcf4-0306-e053-2a95a90accea
Route
topical
Published
Effective Date 2020-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.5 mL)
Inactive Ingredients
propylene glycol glycerin carbomer 980 water aminomethylpropanol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-01

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 75% v/v. Purpose: Antiseptic


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Deposit a dime size amount of product onto palm of hand.
  • Rub hands together until dry.
Inactive Ingredients

Aminomethylpropanol, carbopol 980 polymer, glycerin, propylene glycol, sterile distilled water.

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

For hand-washing to decrease bacteria on the skin.

Section 50565-1

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

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.







Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.







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

Do Not Use

Stop use and ask doctor if irritation and redness develop.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

30mL NDC: 72922-014-01


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Deposit a dime size amount of product onto palm of hand.
  • Rub hands together until dry.
Inactive Ingredients (Inactive ingredients)

Aminomethylpropanol, carbopol 980 polymer, glycerin, propylene glycol, sterile distilled water.

Use

For hand-washing to decrease bacteria on the skin.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.







Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.







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

Do Not Use (Do not use)

Stop use and ask doctor if irritation and redness develop.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

30mL NDC: 72922-014-01


Advanced Ingredient Data


Raw Label Data

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