SPL v4
SPL
SPL Set ID a6a94205-a9ff-7709-e053-2995a90a066b
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Aminomethyl Propanediol Carbomer 934

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-29
Description

Antiseptic, Hand Sanitizer

Purpose

Antiseptic, Hand Sanitizer

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

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 redness develops, condition persists for more than 72 hours consult a doctor.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 55106-9

Ethyl Alcohol 75%

Warnings

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

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
Other Information
  • Store at normal room temperature
  • May discolor certain fabrics
  • May be harmful to wood finishes and plastics
Inactive Ingredients

aqua, glycerin, carbomer, aminomethyl propanol

Package Label Principal Display Panel

Structured Label Content

Use

To help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

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 redness develops, condition persists for more than 72 hours consult a doctor.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 55106-9 (55106-9)

Ethyl Alcohol 75%

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
Other Information (Other information)
  • Store at normal room temperature
  • May discolor certain fabrics
  • May be harmful to wood finishes and plastics
Inactive Ingredients (Inactive ingredients)

aqua, glycerin, carbomer, aminomethyl propanol

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: 2026-02-15T12:05:16.375896 · Updated: 2026-03-14T23:06:47.753582