80593-003

80593-003
SPL v2
SPL
SPL Set ID b2f057ca-e7c6-3c9f-e053-2a95a90a3337
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Aloe Vera Leaf Phenoxyethanol Water Polysorbate 20 Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

To decrease bacteria on the skin that could cause disease

Section 50565-1

Keep out of 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 and redness develop

condition persists for more than 72 hours.

Section 50567-7

keep out of eyes.In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Warnings

For external use only

When using this product

keep out of eyes.In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Do Not Use

/

Other Information

keep containers tightly closed in a dry, cool and well-ventilated place.

recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

aloe barbadensis leaf juice, phenoxyethanol, polysorbate 20, propylene glycol,

tocopheryl acetate, water

Package Label Principal Display Panel


Structured Label Content

Use

To decrease bacteria on the skin that could cause disease

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 50566-9 (50566-9)

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours.

Section 50567-7 (50567-7)

keep out of eyes.In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Purpose

Antibacterial

Warnings

For external use only

When using this product

keep out of eyes.In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Do Not Use (Do not use)

/

Other Information (Other information)

keep containers tightly closed in a dry, cool and well-ventilated place.

recommended storage temperature: 32°F to 104°F (0°C to 40°C)

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, phenoxyethanol, polysorbate 20, propylene glycol,

tocopheryl acetate, water

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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