47993-320

47993-320
SPL v1
SPL
SPL Set ID a3a118de-b4f1-4d8a-9467-9e209a5db931
Route
TOPICAL
Published
Effective Date 2020-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Glycerin Carbomer 940 Aloe Vera Leaf Aminomethylpropanol Tocopherol Ferrosoferric Oxide Ferric Oxide Yellow D&c Red No. 30

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-03
Description

Active Ingredients Ethyl alcohol 62% 

Medication Information

Warnings and Precautions

Warnings:

Flammable. Keep away from fire and flame.

For external use only.

Indications and Usage

Uses：

For sanitizing hands to reduce bacteria and viruses on the skin.

Dosage and Administration

Directions:

Apply small amount in your palm and briskly rub hands together until dry.

Description

Active Ingredients Ethyl alcohol 62% 

Section 50565-1

Keep out of reach of children or pets.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

Do not put in eyes.

Section 51727-6

Inactive Ingredients:

Water, Glycerin, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Vitamin E, Iron Oxide(CI 77499),

Iron Oxide(CI 77492), D&C Red No.30.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active Ingredients

Ethyl alcohol 62% 

Structured Label Content

Indications and Usage (34067-9)

Uses：

For sanitizing hands to reduce bacteria and viruses on the skin.

Dosage and Administration (34068-7)

Directions:

Apply small amount in your palm and briskly rub hands together until dry.

Warnings and Precautions (34071-1)

Warnings:

Flammable. Keep away from fire and flame.

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children or pets.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

Do not put in eyes.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Glycerin, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Vitamin E, Iron Oxide(CI 77499),

Iron Oxide(CI 77492), D&C Red No.30.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

Ethyl alcohol 62% 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:59.638652 · Updated: 2026-03-14T22:58:47.860892