SPL v2
SPL
SPL Set ID a3defdd6-3b67-a2ae-e053-2a95a90a681f
Route
TOPICAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65.6 mL)
Inactive Ingredients
Propylene Glycol Aloe Tocopherol Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 Fd&c Yellow No. 5 Trolamine Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24
Description

Ethyl Alcohol 70.0% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70.0% v/v

Uses

Hand sanitizer to help reduce bacteria on skin.

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 doctor if iffitation or rash appears and lasts.

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 extrnal use only. Flammable. Keep away from heat or flame.

Directions:
  • Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Ethyl Alcohol 70.0% v/v

Other Information:
  • Store below 106°F. (41°C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

Water(Aqua), Carbomer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol, Triethanolamine, Propylene Glycol, FD&C Blue No.1, FD&C Yellow No.5

Package Label Principal Display Panel

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on skin.

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 doctor if iffitation or rash appears and lasts.

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 extrnal use only. Flammable. Keep away from heat or flame.

Directions:
  • Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient (Active ingredient)

Ethyl Alcohol 70.0% v/v

Other Information:
  • Store below 106°F. (41°C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Water(Aqua), Carbomer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol, Triethanolamine, Propylene Glycol, FD&C Blue No.1, FD&C Yellow No.5

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: 2026-02-15T11:57:42.600466 · Updated: 2026-03-14T22:56:56.523889