Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3ba53656-b678-40e7-914f-85d396dd8e17
Route
TOPICAL
Published
Effective Date 2015-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.19 g)
Inactive Ingredients
Cocamidopropyl Betaine Edetate Disodium Methylparaben Bombyx Mori Fiber Acorus Calamus Root Rosemary Glycyrrhizinate Dipotassium Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-09-05

Description

Benzalkonium Chloride 0.1%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Indications and Usage

Provide sanitizing when soap and water not available

Kill or reduces 99.9 of harmful bacteria/germs

Dosage and Administration

Pump 2—3 times onto hand and rub adequately to make bubble

Apply over top of head and wipe with towel after use

Description

Benzalkonium Chloride 0.1%

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Cocamidopropyl Betaine, Disodium EDTA, Methylparaben, Hydrolyzed Silk, Dimethicone Copolyol, Acorus Calamus Root Extract, Rosmarinus Officinalis (Rosemary) Extract, Dipotassium Glycyrrhizate, Lactobacillus/Aloe Barbadensis Ferment Filtrate, perfume, Water

Section 51945-4

Section 55105-1

Antibacterial

Section 55106-9

Benzalkonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Provide sanitizing when soap and water not available

Kill or reduces 99.9 of harmful bacteria/germs

Dosage and Administration (34068-7)

Pump 2—3 times onto hand and rub adequately to make bubble

Apply over top of head and wipe with towel after use

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Cocamidopropyl Betaine, Disodium EDTA, Methylparaben, Hydrolyzed Silk, Dimethicone Copolyol, Acorus Calamus Root Extract, Rosmarinus Officinalis (Rosemary) Extract, Dipotassium Glycyrrhizate, Lactobacillus/Aloe Barbadensis Ferment Filtrate, perfume, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

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