Drug Facts 76378-021

Drug Facts 76378-021
SPL v3
SPL
SPL Set ID bf4d17d7-69c8-4844-a853-585a8f9c5eca
Route
TOPICAL
Published
Effective Date 2018-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.6 g)
Inactive Ingredients
Water Sodium Lauryl Sulfate Sodium Laureth-3 Sulfate Cocamidopropyl Betaine Propylene Glycol Edetate Sodium Isopropyl Alcohol Lauramine Oxide Boric Acid Peg-75 Lanolin Dmdm Hydantoin Aloe Vera Leaf Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-14

Description

Active Ingredient PCMX (para-chloro-meta-xylenol) 0.6%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

for hand-washing to decrease bacteria on the skin

Dosage and Administration

Directions

ready to use

do not dilute

wet hands and forearms

apply 5 milliliters (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Description

Active Ingredient PCMX (para-chloro-meta-xylenol) 0.6%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

irritation and redness develop

Section 50567-7

When using this product

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Section 51727-6

Inactive Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine Oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FDC Blue #1, FDC Yellow #5

Section 51945-4

Servo-Stat P

Liquid Antiseptic Hand Wash

NDC # 76378-021-02

11108R-A1000

1000 ml (33.8 fl oz.)

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

PCMX (para-chloro-meta-xylenol) 0.6%


Structured Label Content

Indications and Usage (34067-9)

Use

for hand-washing to decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

ready to use

do not dilute

wet hands and forearms

apply 5 milliliters (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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 and redness develop

Section 50567-7 (50567-7)

When using this product

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine Oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FDC Blue #1, FDC Yellow #5

Section 51945-4 (51945-4)

Servo-Stat P

Liquid Antiseptic Hand Wash

NDC # 76378-021-02

11108R-A1000

1000 ml (33.8 fl oz.)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

PCMX (para-chloro-meta-xylenol) 0.6%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)