54622-312

54622-312
SPL v2
SPL
SPL Set ID c846eb52-3db4-1a74-e053-2a95a90aa84d
Route
TOPICAL
Published
Effective Date 2021-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
D&c Yellow No. 10 .alpha.-tocopherol Acetate Oat Laurtrimonium Chloride Glycerin Sodium Pyrrolidone Carboxylate Anhydrous Citric Acid Oleth-10 Water D&c Green No. 5 Aloe Vera Leaf Lauramine Oxide Edetate Sodium Acai Lauryl Betaine Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-29

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

Handwash to help reduce bacteria that potentially can cause disease.

Section 42229-5

Drug Facts

Section 51945-4

Stop Use

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Warnings

For external use only

directions

Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly.

Active Ingredient

Benzalkonium chloride, 0.13%

inactive Ingredients

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Euterpe Oleracea Fruit Extract, Oleth-10, Tetrasodium EDTA, Citric Acid, Green 5, Yellow 10, Fragrance

when Using This Product

Avoid contact with eyes. In case of eye contact, flush with water.

keep Out of Reach of Children.

If swallowed, seek immediate medical attention or call a poison control center.


Structured Label Content

Use

Handwash to help reduce bacteria that potentially can cause disease.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Purpose

Antiseptic

Stop Use (Stop use)

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

Warnings

For external use only

directions (Directions)

Wet hands, apply soap, rub hands together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly.

Active Ingredient (Active ingredient)

Benzalkonium chloride, 0.13%

inactive Ingredients (Inactive ingredients)

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Euterpe Oleracea Fruit Extract, Oleth-10, Tetrasodium EDTA, Citric Acid, Green 5, Yellow 10, Fragrance

when Using This Product (When using this product)

Avoid contact with eyes. In case of eye contact, flush with water.

keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek immediate medical attention or call a poison control center.


Advanced Ingredient Data


Raw Label Data

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