75606-002

75606-002
SPL v1
SPL
SPL Set ID b1d4cdc1-0cd0-0a8a-e053-2995a90aee01
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
Aloe Vera Leaf Fragrance Lemon Orc2001060 Phenoxyethanol Glycerin .alpha.-tocopherol Acetate Water

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

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.

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

hold can upright 6” to 8” from hand

spray 3 to 4 seconds until covered with mist

for children under 6, use only under adult supervision

not recommended for infants

Do Not Use

/

Other Information

contents under pressure

keep away from heat, spartks and open flame

do not puncture or incinerate container

keep in a dry, cool and well-ventilated place

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

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

aloe barbadensis leaf extract, fragrance, glycerin, phenoxyethanol, 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)

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.

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

hold can upright 6” to 8” from hand

spray 3 to 4 seconds until covered with mist

for children under 6, use only under adult supervision

not recommended for infants

Do Not Use (Do not use)

/

Other Information (Other information)

contents under pressure

keep away from heat, spartks and open flame

do not puncture or incinerate container

keep in a dry, cool and well-ventilated place

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

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, fragrance, glycerin, phenoxyethanol, tocopheryl acetate, water

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


Advanced Ingredient Data


Raw Label Data

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