80153-001 Antibacterial Wipes 0.13% Benzalkonium Chloride

80153-001 Antibacterial Wipes 0.13% Benzalkonium Chloride
SPL v1
SPL
SPL Set ID ad44a1fa-7e89-6295-e053-2a95a90adb89
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 Phenoxyethanol Polysorbate 20 Water Aloe Vera Leaf Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-20

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.

Warnings

For external use only.

When using this product■Keep out of eyes.

In case of contact with eyes, flush thoroughly

with water. I I Avoid contact with broken skin

Stop use and ask a doctor if■irritation and

redness develop■condition persists for more

than 72 hours.

Directions

Wet hands thoroughly with product

and allow to dry without wiping■for

children under 6, use only under adult

supervision■not recommended for

infants

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

aloe barbadensis leaf juice, fragrance,

phenoxyethanol, polysorbate 20,

propylene glycol, tocopheryI 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.

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. I I Avoid contact with broken skin

Stop use and ask a doctor if■irritation and

redness develop■condition persists for more

than 72 hours.

Directions

Wet hands thoroughly with product

and allow to dry without wiping■for

children under 6, use only under adult

supervision■not recommended for

infants

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, fragrance,

phenoxyethanol, polysorbate 20,

propylene glycol, tocopheryI acetate,

water

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


Advanced Ingredient Data


Raw Label Data

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