74743-017

74743-017
SPL v1
SPL
SPL Set ID b59ba2b0-5064-dbff-e053-2a95a90aebb0
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
Polysorbate 20 Edetate Sodium Polyquaternium-10 (1000 Mpa.s At 2%) Fragrance Lavender & Chia F-153480 Phenoxyethanol Water

Identifiers & Packaging

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

Description

BENZALKONIUM CHLORIDE 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

BENZALKONIUM CHLORIDE 0.13%

Use

Hand Sanitizer to help reduce bacteria on skin

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if imtation or rash appears and lasts.

Section 50567-7

When using this product,

do not use in or near the eyes. In case of contaot, rinse eyes thoroughly with water.

Stop use and ask doctor if imtation or rash appears and lasts.

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

Warnings

For external use only, Keep out of reach of children.

Directions

Open the cap and gently squeeze product into palm of hands, then rub throughly over all surfaces of both hands.

Do Not Use

do not use in or near the eyes. In case of contaot, rinse eyes thoroughly with water.

Other Information

Store between 59-86F(15-30C). Avoid freezing and excessive heat above 104F (40C).

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.13%

Inactive Ingredients

WATER (AQUA).

FRAGRANCE (PARFUM), PHENOXYETHANOL,

POLYQUATERNIUM-10, POLYSORBATE 20,

TETRASODIUM EDTA.

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on skin

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if imtation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product,

do not use in or near the eyes. In case of contaot, rinse eyes thoroughly with water.

Stop use and ask doctor if imtation or rash appears and lasts.

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

Purpose

Antiseptic

Warnings

For external use only, Keep out of reach of children.

Directions

Open the cap and gently squeeze product into palm of hands, then rub throughly over all surfaces of both hands.

Do Not Use (Do not use)

do not use in or near the eyes. In case of contaot, rinse eyes thoroughly with water.

Other Information (Other information)

Store between 59-86F(15-30C). Avoid freezing and excessive heat above 104F (40C).

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.13%

Inactive Ingredients (Inactive ingredients)

WATER (AQUA).

FRAGRANCE (PARFUM), PHENOXYETHANOL,

POLYQUATERNIUM-10, POLYSORBATE 20,

TETRASODIUM EDTA.

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


Advanced Ingredient Data


Raw Label Data

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