SPL v2
SPL
SPL Set ID 5847a304-ff8e-4ae1-8bf0-ee7e6efb9451
Route
TOPICAL
Published
Effective Date 2012-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (6.0 mg)
Inactive Ingredients
Aloe Vera Leaf Coco Diethanolamide Cocamidopropyl Betaine Diazolidinyl Urea Propylene Glycol Water Sodium Chloride Sodium Laureth Sulfate Edetate Sodium Alpha-tocopherol Acetate Propylparaben Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-01

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses
  • for handwashing to decrease bacteria on skin. Recommended for repeated use.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50567-7

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Warnings

For external use only.

Directions
  • wet hands and forearms
  • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 30 seconds
  • supervise children under 6 years of age
Active Ingredient

Chloroxylenol (PCMX) 0.6%

Inactive Ingredients

aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA

Made in U.S.A.

Stop Use and Ask Doctor If
  • irritation and redness develops and persists for more than 72 hours
Principal Display Panel – 27.05 Fl. Oz. Box Label

Henry Schein

112-5990

Maxiclens

Antimicrobial Hand Wash

NDC 0404-5990-01

27.05 FL. OZ. (800 ML)


Structured Label Content

Uses
  • for handwashing to decrease bacteria on skin. Recommended for repeated use.
Section 42229-5 (42229-5)

Drug Facts

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 50567-7 (50567-7)

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • wet hands and forearms
  • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 30 seconds
  • supervise children under 6 years of age
Active Ingredient

Chloroxylenol (PCMX) 0.6%

Inactive Ingredients

aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA

Made in U.S.A.

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • irritation and redness develops and persists for more than 72 hours
Principal Display Panel – 27.05 Fl. Oz. Box Label (PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label)

Henry Schein

112-5990

Maxiclens

Antimicrobial Hand Wash

NDC 0404-5990-01

27.05 FL. OZ. (800 ML)


Advanced Ingredient Data


Raw Label Data

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