SPL v3
SPL
SPL Set ID a56617e9-c37b-47c8-820c-e736f864f791
Route
TOPICAL
Published
Effective Date 2012-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Aminomethylpropanol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Fd&c Blue No. 1 D&c Red No. 33 Fd&c Yellow No. 5 Glycerin Propylene Glycol Water Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-15
Description

Active ingredient Ethyl 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 and 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 20C-25C (68F to 77F).
  • may discolor fabrics.
Description

Active ingredient Ethyl 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 and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Section 50567-7
When using this product

avoid contact with eyes. In case of contact flush eyes with water.
Section 51727-6

Inactive Ingredients

Aminomethyl propanol, Carbomer 940, FD&C Blue No. 1 (for winter wonderland scented, apple harvest scented & cherry blossom scented), FD&C Red No. 33 (for winter wonderland scented & apple harvest scented), FD&C Red No. 4(for cherry blossom scented), FD&C Yellow No. 5 (for winter wonderland scented, apple harvest scented & cherry blossom scented), Fragrance, Glycerin, Propylene glycol, Water.

Section 51945-4
Section 55105-1
Purpose

Antiseptic
Section 55106-9
Active ingredient

Ethyl 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 20C-25C (68F to 77F).
  • 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 and 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 and ask a doctor if redness or irritation develop and persist for more than 72 hours.
Section 50567-7 (50567-7)
When using this product

avoid contact with eyes. In case of contact flush eyes with water.
Section 51727-6 (51727-6)

Inactive Ingredients

Aminomethyl propanol, Carbomer 940, FD&C Blue No. 1 (for winter wonderland scented, apple harvest scented & cherry blossom scented), FD&C Red No. 33 (for winter wonderland scented & apple harvest scented), FD&C Red No. 4(for cherry blossom scented), FD&C Yellow No. 5 (for winter wonderland scented, apple harvest scented & cherry blossom scented), Fragrance, Glycerin, Propylene glycol, Water.

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

Antiseptic
Section 55106-9 (55106-9)
Active ingredient

Ethyl Alcohol 62%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:30.550099 · Updated: 2026-03-14T22:53:15.110984