SPL v1
SPL
SPL Set ID ab7ad43a-53a0-0eda-e053-2a95a90a5c98
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1677 g)
Inactive Ingredients
Citral Geraniol Benzyl Salicylate Farnesol Edetate Disodium Anhydrous Sodium Benzoate Water Citric Acid Monohydrate Glycerin Polysorbate 80 .alpha.-tocopherol Acetate Benzyl Benzoate Maltodextrin Limonene, (+)- .beta.-citronellol, (r)- Eugenol Isoeugenol Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-15

Description

benzalkonium chloride


Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

When using this product keep out of eyes. in case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin.

do not inhale or ingest.

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.

Indications and Usage

Wipe hands thoroughly with product and allow to dry.

Discard wipe in trash. Do not flush.

Dosage and Administration

for external use only

Description

benzalkonium chloride

Section 50565-1

keep out of reach of the children

Section 51727-6

water, glycerin, polysorbate 80, sodium benzoate, benzalkonium chloride, citric acid, maltodextrin, aloe barbadensis leaf juice powder, limonene, tocopheryl acetate, linalool, citral, citronellol, geraniol, benzyl benzoate, benzyl salicylate, farnesol, eugenol, isoeugenol, benzyl alcohol, fragrance

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

benzalkonium chloride


Structured Label Content

Indications and Usage (34067-9)

Wipe hands thoroughly with product and allow to dry.

Discard wipe in trash. Do not flush.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

When using this product keep out of eyes. in case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin.

do not inhale or ingest.

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.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, glycerin, polysorbate 80, sodium benzoate, benzalkonium chloride, citric acid, maltodextrin, aloe barbadensis leaf juice powder, limonene, tocopheryl acetate, linalool, citral, citronellol, geraniol, benzyl benzoate, benzyl salicylate, farnesol, eugenol, isoeugenol, benzyl alcohol, fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

benzalkonium chloride


Advanced Ingredient Data


Raw Label Data

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