Luckyhndsoapchlrxynl

Luckyhndsoapchlrxynl
SPL v3
SPL
SPL Set ID 8119dcb5-a733-6e49-e053-2a91aa0ad5bd
Route
TOPICAL
Published
Effective Date 2019-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.3 g)
Inactive Ingredients
Citric Acid Monohydrate Ammonium Lauryl Sulfate Edetate Sodium Tetrahydrate Water Fd&c Red No. 40 Cocamidopropyl Betaine Ammonium Chloride Dmdm Hydantoin Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-01

Description

Chloroxylenol 0.3%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Chloroxylenol 0.3%

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only

Directions

■ pump into hands, wet as needed ■ lather vigorously for at least 15 seconds ■ wash skin, rinse thoroughly and dry

Package Label

Active Ingredient

Chloroxylenol 0.3%

Inactive Ingredients

water (aqua), ammonium lauryl sulfate, cocamidopropyl betaine, ammonium chloride, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 40

When Using This Product

■ avoid contact with the eyes. In case of eye contact, flush with water.

Stop Use and Ask A Doctor If

■ irritation and redness develops

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for handwashing to decrease bacteria on the skin

Purpose

Antibacterial

Warnings

For external use only

Directions

■ pump into hands, wet as needed ■ lather vigorously for at least 15 seconds ■ wash skin, rinse thoroughly and dry

Package Label

Active Ingredient (Active ingredient)

Chloroxylenol 0.3%

Inactive Ingredients (Inactive ingredients)

water (aqua), ammonium lauryl sulfate, cocamidopropyl betaine, ammonium chloride, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 40

When Using This Product (When using this product)

■ avoid contact with the eyes. In case of eye contact, flush with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ irritation and redness develops

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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