a611ee21-d63d-8204-e053-2a95a90a0e55

SPL v2
SPL
SPL Set ID a611ee21-d63d-8204-e053-2a95a90a0e55
Route
topical
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
trolamine carbomer homopolymer type b (allyl pentaerythritol crosslinked) water glycerin butylene glycol hyaluronate sodium 1,2-hexanediol aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-19

Purpose

Antiseptic

Description

Alcohol 75% v/v


Medication Information

Warnings

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

Purpose

Antiseptic

Directions
  • Place enough product on your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Other Information
  • Store between 15-30 °C (59-86°F).
  • Avoid freezing and excessive heat above 104°F(40°C).
  • May discolor certain fabrics or surface.
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Description

Alcohol 75% v/v

Use
  • Hand sanitizer to help reduce bacteria that potentially can 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, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Active Ingredient

Alcohol 75% v/v

Package Label Principal Display Panel


Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions
  • Place enough product on your palm to thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Other Information
  • Store between 15-30 °C (59-86°F).
  • Avoid freezing and excessive heat above 104°F(40°C).
  • May discolor certain fabrics or surface.
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Use
  • Hand sanitizer to help reduce bacteria that potentially can 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, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Active Ingredient

Alcohol 75% v/v

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)