SPL v1
SPL
SPL Set ID a8a548c0-ac25-430f-e053-2995a90a0400
Route
TOPICAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Trolamine Levomenthol Glycerin Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Water Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-22

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Use
  • to decrease bacteria on the skin that could cause disease
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 rash occurs. These may be signs of serious condition.
Section 50567-7

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
Warnings

For external use only : hands

Flammable. Keep away from heat or flame.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years should be supervised when using this product
Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Other Information
  • Store between 59-86°F (15-30°C)
  • Avoid freezing and excessive heat above 104°F (40°C)
  • Do not use on children under two months of age.
Inactive Ingredients

Water, Glycerin, Carbomer, Trolamine, L-Menthol, Green Tea Leaf, Aloe Vera Leaf

Package Label Principal Display Panel


Structured Label Content

Use
  • to decrease bacteria on the skin that could cause disease
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 rash occurs. These may be signs of serious condition.
Section 50567-7 (50567-7)

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
Purpose

Antiseptic

Warnings

For external use only : hands

Flammable. Keep away from heat or flame.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years should be supervised when using this product
Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Other Information (Other information)
  • Store between 59-86°F (15-30°C)
  • Avoid freezing and excessive heat above 104°F (40°C)
  • Do not use on children under two months of age.
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Trolamine, L-Menthol, Green Tea Leaf, Aloe Vera Leaf

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


Advanced Ingredient Data


Raw Label Data

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