SPL v3
SPL
SPL Set ID a8d482d1-2925-107f-e053-2995a90ab812
Route
TOPICAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (84 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

WARNINGS

For external use only.

Do not use in eyes.

When using this product avoid contact with eyes. In case of eye contact flush with water. Stop use and ask doctor if irritation and redness develop.

Keep out of reach of children.

If swallowed, get medical attention or contact a Poison Control Center.

Indications and Usage

USES: to reduce bacteria on skin that could cause disease. Recommended for repeat use.

Dosage and Administration

Apply liberally to hands and gently rub until dry. Reapply after 4 hours.

Description

Benzalkonium Chloride 0.13%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask doctor if irritation or redness develop.

Section 50567-7

Avoid contact with eyes. In case of eye contact flush with plenty of water.

Section 51727-6

3-(trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Ethyl Alcohol, Water

Section 51945-4

Hand Protector label 79291-653-03 16oz (473mL)

Section 53413-1

Contact:

Cytonix LLC, Beltsville, MD

20705 USA 301-470-6267

www.cytonix.com

Section 55105-1

Purpose: Antiseptic. Hand and skin sanitizer.

Section 55106-9

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

USES: to reduce bacteria on skin that could cause disease. Recommended for repeat use.

Dosage and Administration (34068-7)

Apply liberally to hands and gently rub until dry. Reapply after 4 hours.

Warnings and Precautions (34071-1)

WARNINGS

For external use only.

Do not use in eyes.

When using this product avoid contact with eyes. In case of eye contact flush with water. Stop use and ask doctor if irritation and redness develop.

Keep out of reach of children.

If swallowed, get medical attention or contact a Poison Control Center.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation or redness develop.

Section 50567-7 (50567-7)

Avoid contact with eyes. In case of eye contact flush with plenty of water.

Section 51727-6 (51727-6)

3-(trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Ethyl Alcohol, Water

Section 51945-4 (51945-4)

Hand Protector label 79291-653-03 16oz (473mL)

Section 53413-1 (53413-1)

Contact:

Cytonix LLC, Beltsville, MD

20705 USA 301-470-6267

www.cytonix.com

Section 55105-1 (55105-1)

Purpose: Antiseptic. Hand and skin sanitizer.

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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