SPL v2
SPL
SPL Set ID a9d4d100-44e1-dd96-e053-2995a90a0a5e
Route
TOPICAL
Published
Effective Date 2020-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Fd&c Yellow No. 5 Sodium Hydroxide Fd&c Red No. 4 Glycereth-26 Carboxypolymethylene Fd&c Blue No. 1 Fd&c Red No. 40 Water Aloe D&c Red No. 33

Identifiers & Packaging

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

Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 75%

Use

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

Label

Warnings

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

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 75%

Other Information

Store below 106 F(41 C)

Inactive Ingredients

water

glycereth-26

aloe barbadensis extract,

carbomer,

sodium hydroxide,

may contain: red 33, red 4, yellow 5, blue 1, red 40.

When Using This Product

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

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.

Structured Label Content

Use

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

Label

Purpose

Antiseptic

Warnings

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

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient (Active ingredient)

Alcohol 75%

Other Information (Other information)

Store below 106 F(41 C)

Inactive Ingredients (Inactive ingredients)

water

glycereth-26

aloe barbadensis extract,

carbomer,

sodium hydroxide,

may contain: red 33, red 4, yellow 5, blue 1, red 40.

When Using This Product (When using this product)

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 (Stop use and ask a doctor)

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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:23.632652 · Updated: 2026-03-14T22:57:55.937889