66949-129 / 3094 round one ab

66949-129 / 3094 round one ab
SPL v6
SPL
SPL Set ID b44021d1-33cf-5e6e-e053-2995a90aa07c
Route
topical
Published
Effective Date 2017-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chloroxylenol (0.4 g)
Inactive Ingredients
methacrylic acid - ethyl acrylate copolymer (1:1) type a c11-13 pareth-6 titanium dioxide palmitostearic acid methylisothiazolinone attapulgite water sodium c14-16 olefin sulfonate pumice peg-75 lanolin methylchloroisothiazolinone glutaral cocamidopropyl hydroxysultaine dipotassium 4',5'-dibromofluorescein fd&c yellow no. 5 stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-07-19

Purpose

Antiseptic Handwash

Description

Chloroxylenol 0.4%


Medication Information

Warnings

For external use only.

Uses

Hand washing to decrease bacteria on skin

Purpose

Antiseptic Handwash

Directions
  • Wet hands with water.
  • Place hands under dispenser and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
  • Rinse hands thoroughly and dry.
Other Information
  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.
Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Pumice, Cocamidopropyl Hydroxysultaine, Stearic Acid, Methacrylic Acid Copolymer, Attapulgite, C11-13 Pareth-6, PEG-75 Lanolin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Titanium Dioxide, Palmitostearic Acid, Orange 7, Yellow 5

Description

Chloroxylenol 0.4%

Section 51945-4

Do Not Use

Do not use in or around the eyes.

Active Ingredient

Chloroxylenol 0.4%

Questions Or Comments?

Call 1-877-I-BUY-ZEP (1-877-428-9937)

When Using This Product
  • If eye contact occurs, rinse promptly and thoroughly with water.
  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
Stop Use and Ask A Doctor

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

Keep Out of Reach of Children

Keep out of reach of children except under adult supervision.


Structured Label Content

Warnings

For external use only.

Uses

Hand washing to decrease bacteria on skin

Purpose

Antiseptic Handwash

Directions
  • Wet hands with water.
  • Place hands under dispenser and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
  • Rinse hands thoroughly and dry.
Other Information (Other information)
  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.
Inactive Ingredients (Inactive ingredients)

Water, Sodium C14-16 Olefin Sulfonate, Pumice, Cocamidopropyl Hydroxysultaine, Stearic Acid, Methacrylic Acid Copolymer, Attapulgite, C11-13 Pareth-6, PEG-75 Lanolin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Titanium Dioxide, Palmitostearic Acid, Orange 7, Yellow 5

Section 51945-4 (51945-4)

Do Not Use (Do not use)

Do not use in or around the eyes.

Active Ingredient

Chloroxylenol 0.4%

Questions Or Comments? (Questions or comments?)

Call 1-877-I-BUY-ZEP (1-877-428-9937)

When Using This Product (When using this product)
  • If eye contact occurs, rinse promptly and thoroughly with water.
  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

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

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children except under adult supervision.


Advanced Ingredient Data


Raw Label Data

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