SPL v2
SPL
SPL Set ID a74e271e-dd51-77c6-e053-2995a90a34a9
Route
TOPICAL
Published
Effective Date 2020-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1 mL)
Inactive Ingredients
Carbomer 940 Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Antiseptic, Hand Sanitizer

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Dosage and Administration

Place enough on hands to cover all surfaces. Rub hands until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Description

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor is rash or irritation occurs. This may be a sign of a serious condition.

Section 50567-7

When using this product keep out of the eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if rash or irritation occurs. These may be signs of a serious condition.

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50570-1

-In children less than 2 months of age

-On open skin wounds

Warnings

For external use only. Flammable. Keep away from heat or flame.

Other Information

Store between 15-50C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Glycerine USP, Carbomer, TEA

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

Place enough on hands to cover all surfaces. Rub hands until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor is rash or irritation occurs. This may be a sign of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of the eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if rash or irritation occurs. These may be signs of a serious condition.

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

-In children less than 2 months of age

-On open skin wounds

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from heat or flame.

Other Information

Store between 15-50C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Glycerine USP, Carbomer, TEA

Package Label Principal Display Panel


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)