SPL v1
SPL
SPL Set ID 9f78e110-7e3c-4210-bfbe-bf62a8d441c2
Route
TOPICAL
Published
Effective Date 2021-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70.0882 L)
Inactive Ingredients
Glycerin Water Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-12

Description

Ethyl Alcohol 70% v/v

Purpose

Antibacterial


Medication Information

Warnings and Precautions

Warning Flammable. Keep away from fire or flame. For external use only.

Indications and Usage

Uses  Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

Purpose

Antibacterial

Dosage and Administration

Directions Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Description

Ethyl Alcohol 70% v/v

Section 44425-7

Other Information Store under 105°F. 

Section 50565-1

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50567-7

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

Section 51727-6

Inactive Ingredients Purified water, Glycerin USP, Carbomer

Section 51945-4

Active Ingredients

Ethyl Alcohol 70% v/v


Structured Label Content

Indications and Usage (34067-9)

Uses  Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

Dosage and Administration (34068-7)

Directions Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Warnings and Precautions (34071-1)

Warning Flammable. Keep away from fire or flame. For external use only.

Section 44425-7 (44425-7)

Other Information Store under 105°F. 

Section 50565-1 (50565-1)

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients Purified water, Glycerin USP, Carbomer

Section 51945-4 (51945-4)

Purpose

Antibacterial

Active Ingredients

Ethyl Alcohol 70% v/v


Advanced Ingredient Data


Raw Label Data

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