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Drug Facts
Antibacterial Hand Soap
FDA Label NDC 0404-4438
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein, Inc. for the product Antibacterial Hand (NDC 0404-4438). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Chloroxylenol (PCMX) 0.6%
Purpose
Antiseptic
Uses
For handwashing to decrease bacteria on skin. Recommended for repeated use.
Warnings
For external use only.
When Using This Product
- supervise children under 6
- do not use in the eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask doctor if irritation or redness develop and persist for more than 72 hours.
Otc - 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.
Directions
Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.
Inactive Ingredients
aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate
Principal Display Panel – 473 Ml (16 Fl. Oz.) Bottle
Henry Schein
Antibacterial
HAND SOAP
Cucumber & Aloe
Jabón de manos
antibacteriano
Savon antibactérien
pour les mains
Distributed by:
Distribuido por: Distribué par:
HENRY SCHEIN, Inc.
135 Duryea Road
Melville, NY 11747 USA
16 fl. oz. • 473 ml
Principal Display Panel – 473 mL (16 Fl. Oz.) Bottle (Hen09 0001 01)
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