SPL v1
SPL
SPL Set ID ca5429a5-e83c-4011-8c88-070e8b096a06
Route
TOPICAL
Published
Effective Date 2017-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine Fd&c Blue No. 1 D&c Red No. 33 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-12-12
Description

Active ingredient Ethyl Alcohol, 65% v/v

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable, keep away

from fire or flame.

Do not use in or near the eyes

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Indications and Usage

Uses  hand sanitizer to help

reduce bacteria on skin

Dosage and Administration

Directions  Put a dime sized

drop onto hands and rub

together briskly ntil dry.

Description

Active ingredient Ethyl Alcohol, 65% v/v

Section 44425-7

Other information

Store below 110° F (43° C)

Section 50565-1

Keep out of reach of

children. If swallowed, get

medical help or contact a Poison

Control Center right away.

Section 51727-6

Inactive ingredients

water, glycerin, propylene

glycol, fragrance, carbomer,

triethanolamine, blue 1, red

33, yellow 5

Section 51945-4

Section 55105-1

Purpose  Antimicrobial

Section 55106-9

Active ingredient

Ethyl Alcohol, 65% v/v

Structured Label Content

Indications and Usage (34067-9)

Uses  hand sanitizer to help

reduce bacteria on skin

Dosage and Administration (34068-7)

Directions  Put a dime sized

drop onto hands and rub

together briskly ntil dry.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable, keep away

from fire or flame.

Do not use in or near the eyes

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Section 44425-7 (44425-7)

Other information

Store below 110° F (43° C)

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 51727-6 (51727-6)

Inactive ingredients

water, glycerin, propylene

glycol, fragrance, carbomer,

triethanolamine, blue 1, red

33, yellow 5

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose  Antimicrobial

Section 55106-9 (55106-9)

Active ingredient

Ethyl Alcohol, 65% v/v

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.332878 · Updated: 2026-03-14T22:54:56.160161