SPL v1
SPL
SPL Set ID 339252cc-1b23-4bf2-b64e-a12611eaa985
Route
TOPICAL
Published
Effective Date 2014-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-24
Description

Active ingredients Alcohol 62%

Medication Information

Warnings and Precautions

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears or mouth.

Indications and Usage

Uses:

  • Hand sanitizer to help decrease bacteria on the skin.
  • Recommended for repeat use.
Dosage and Administration
Directions:

  • Pump as needed into your palms and thoroughly spread on both hands.

  • Rub into skin until dry.                                                                                                                                                                          
Other information:

  • Store at 20 C - 25 C (68 F - 77 F)
  • May discolor fabrics


Description

Active ingredients Alcohol 62%

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 51727-6

INACTIVE INGREDIENTS:Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Aminomethyl propanol

Section 51945-4
Section 55105-1
Purpose

Antiseptic
Section 55106-9
Active ingredients
Alcohol 62%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Hand sanitizer to help decrease bacteria on the skin.
  • Recommended for repeat use.
Dosage and Administration (34068-7)
Directions:

  • Pump as needed into your palms and thoroughly spread on both hands.

  • Rub into skin until dry.                                                                                                                                                                          
Other information:

  • Store at 20 C - 25 C (68 F - 77 F)
  • May discolor fabrics


Warnings and Precautions (34071-1)

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears or mouth.

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:Water, Glycerin, Propylene Glycol, Carbomer, Fragrance, Aminomethyl propanol

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

Antiseptic
Section 55106-9 (55106-9)
Active ingredients
Alcohol 62%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:50.029743 · Updated: 2026-03-14T22:53:48.902596