SPL v1
SPL
SPL Set ID b06ae6b9-47a6-ad12-e053-2995a90a29dd
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Trolamine Propylene Glycol Glycerin Aloe Carbomer Homopolymer, Unspecified Type Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 70% v/v.

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v.

Use
  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rednees develp and persist for more than 72 hours.

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.

Section 53413-1

1-855-345-5575

Warnings

For external use only. Flammable, keep away from heat or flame

Directions
  • Wet hands thoroughly with product
  • briskly rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store at room temperature
  • may discolor certain fabrics
Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

Package Label Principal Display Panel


Structured Label Content

Use
  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rednees develp and persist for more than 72 hours.

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.

Section 53413-1 (53413-1)

1-855-345-5575

Purpose

Antimicrobial

Warnings

For external use only. Flammable, keep away from heat or flame

Directions
  • Wet hands thoroughly with product
  • briskly rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store at room temperature
  • may discolor certain fabrics
Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

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


Advanced Ingredient Data


Raw Label Data

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