Drug Facts 11429-1006

Drug Facts 11429-1006
SPL v5
SPL
SPL Set ID f5d2c728-568d-4ebc-ae5d-a4ddfd91266e
Route
TOPICAL
Published
Effective Date 2014-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (3 mg)
Inactive Ingredients
Water Sodium Lauryl Sulfate Lauryl Glucoside Cocamidopropyl Betaine Propylene Glycol Sodium Chloride Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-16 Until 2025-06-17

Description

Active Ingredient Choroxylenol 0.3%


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:

Apply to hands, add small amount of water and lather.

Work until soil is emulsified, rinse and wipe dry.

Description

Active Ingredient Choroxylenol 0.3%

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, Propylene Glycol, Sodium Chloride, Fragrance and Glycerin.

Section 51945-4

PK

Lemon Drop

gentle lotion soap

antiseptic

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

Made in USA

Stock # 245

3.78 Liters (1 Gallon)

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Choroxylenol 0.3%


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand washing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions:

Apply to hands, add small amount of water and lather.

Work until soil is emulsified, rinse and wipe 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, Propylene Glycol, Sodium Chloride, Fragrance and Glycerin.

Section 51945-4 (51945-4)

PK

Lemon Drop

gentle lotion soap

antiseptic

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

Made in USA

Stock # 245

3.78 Liters (1 Gallon)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Choroxylenol 0.3%


Advanced Ingredient Data


Raw Label Data

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