Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1fe9ad0d-f339-49f0-b1bd-fbb9dbf10dd8
Route
TOPICAL
Published
Effective Date 2014-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (2.5 mg)
Inactive Ingredients
Water Sodium Lauryl Sulfate Lauryl Glucoside Cocamidopropyl Betaine Decyl Glucoside Dmdm Hydantoin Propylene Glycol Fd&c Blue No. 1 Fd&c Yellow No. 5 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-11

Description

Active Ingredient Chloroxylenol 0.25%


Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

Uses:

For hand washing to decrease bacteria on the skin.

Dosage and Administration

Directions:

For maximum efficiency, pump foam into dry hands, lather vigorously for 30 seconds, rinse and dry.

Description

Active Ingredient Chloroxylenol 0.25%

Section 44425-7

Other Information:

Store at 20 to 25 C. (68 to 77 F)

Section 50565-1

Keep out of reach of children.

Children must be supervised in use of this product.

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

Section 50566-9

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Decyl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol, Fragrance, and FDC Blue #1, FDC Yellow #5, FDC Yellow #6.

Section 51945-4

Total Performance

Antibacterial

Foam Hand Wash

Dist.By:

Chemco

Products Company

Paramount, CA 90723

800-266-2116     chemcoprod.com

Made in the U.S.A.

Stock # WB994310

1000 ml (34 fl. oz.)

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Chloroxylenol 0.25%


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand washing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions:

For maximum efficiency, pump foam into dry hands, lather vigorously for 30 seconds, rinse and dry.

Warnings and Precautions (34071-1)

Warnings:

For external use only

Section 44425-7 (44425-7)

Other Information:

Store at 20 to 25 C. (68 to 77 F)

Section 50565-1 (50565-1)

Keep out of reach of children.

Children must be supervised in use of this product.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Decyl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol, Fragrance, and FDC Blue #1, FDC Yellow #5, FDC Yellow #6.

Section 51945-4 (51945-4)

Total Performance

Antibacterial

Foam Hand Wash

Dist.By:

Chemco

Products Company

Paramount, CA 90723

800-266-2116     chemcoprod.com

Made in the U.S.A.

Stock # WB994310

1000 ml (34 fl. oz.)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Chloroxylenol 0.25%


Advanced Ingredient Data


Raw Label Data

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