SPL v1
SPL
SPL Set ID aeb19629-cf2d-a2ed-e053-2a95a90ab8e3
Route
TOPICAL
Published
Effective Date 2020-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Trolamine Glycerin Water Aloe Vera Leaf Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-07
Description

Alcohol 75% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 a serious condition.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

For external use only. 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 of age should be supervised when using products.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 75% v/v

Other Information
  • Store below 110°F(43°C)
  • Avoid freezing and excessive heat above 104°F(40°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients

Water (Aqua), Glycerin, Carbomer, Parfum, Triethanolamine, Aloe Barbadensis Leaf Extract

Package Label Principal Display Panel

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 a serious condition.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only. 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 of age should be supervised when using products.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 75% v/v

Other Information (Other information)
  • Store below 110°F(43°C)
  • Avoid freezing and excessive heat above 104°F(40°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Carbomer, Parfum, Triethanolamine, Aloe Barbadensis Leaf Extract

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:40.979813 · Updated: 2026-03-14T22:58:21.856728