SPL v1
SPL
SPL Set ID 411ffefe-16e5-a2e0-e063-6394a90a0cd4
Route
TOPICAL
Published
Effective Date 2022-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.5 mg)
Inactive Ingredients
Sodium Laureth Sulfate N-nonylphenol (mixed Isomers) Coco Diethanolamide Benzaldehyde Sodium Chloride Cocamidopropyl Betaine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-03

Description

Active ingredient Benzalkonium chloride 0.15%


Medication Information

Warnings and Precautions

For external use only.

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

When using this product do not use near the eyes. If contact occurs, rinse eyes thoroughly with water.

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

Indications and Usage

• Handwash to help decrease bacteria.

• Recommended for repeated use.

Dosage and Administration

Wet hands. Apply a small amount of soap and work into a lather for 15–30 seconds. Rinse well and dry hands.

Description

Active ingredient Benzalkonium chloride 0.15%

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 if irritation or rash appears and lasts.

Section 50567-7

Do not use near the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3

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

Section 51727-6

Water (aqua), Sodium Laureth Sulfate, Coco Betaine, Coco DEA, Propylene Glycol, Citric acid, Fragrance, Glycol Stearate.

Section 55105-1

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium chloride 0.15%

Principal Display Panel – Antibacterial Hand Soap, Almond Scent, 1 Us Gal (3.78 L)


Structured Label Content

Indications and Usage (34067-9)

• Handwash to help decrease bacteria.

• Recommended for repeated use.

Dosage and Administration (34068-7)

Wet hands. Apply a small amount of soap and work into a lather for 15–30 seconds. Rinse well and dry hands.

Warnings and Precautions (34071-1)

For external use only.

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

When using this product do not use near the eyes. If contact occurs, rinse eyes thoroughly with water.

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

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 if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

Do not use near the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Water (aqua), Sodium Laureth Sulfate, Coco Betaine, Coco DEA, Propylene Glycol, Citric acid, Fragrance, Glycol Stearate.

Section 55105-1 (55105-1)

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium chloride 0.15%

Principal Display Panel – Antibacterial Hand Soap, Almond Scent, 1 Us Gal (3.78 L) (Principal Display Panel – Antibacterial Hand Soap, Almond Scent, 1 US gal (3.78 L))


Advanced Ingredient Data


Raw Label Data

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