Zitfree

Zitfree
SPL v3
SPL
SPL Set ID 70c2e3fb-e643-467b-80fd-c40e3c3e9513
Route
TOPICAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Hypromellose, Unspecified Laureth-4 Methylparaben Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-01

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Uses
  • treats acne
  • dries acne pimples and allows skin to heal
  • helps prevent new acne pimples from forming
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50566-9

Stop use and consult a doctor if irritation becomes severe.

Section 50570-1

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only.

Directions
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer up to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, use sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient

Benzoyl peroxide 10%

Other Information
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, methylparaben, purified water, sodium hydroxide

Questions Or Comments?

866-323-0107 or visit www.natureplex.com

When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Principal Display Panel 28 G Tube Carton

NDC 67234-035-01

Natureplex

MAXIMUM STRENGTH

ZitFree

Acne Treatment Cream

* Compare to the

active ingredient of

Clearasil ® Daily

Clear ® Vanishing

Acne Treatment Cream

Oil-Free, Odorless Cream Disappears As It Works

NET WT 1 OZ (28g)


Structured Label Content

Uses
  • treats acne
  • dries acne pimples and allows skin to heal
  • helps prevent new acne pimples from forming
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50566-9 (50566-9)

Stop use and consult a doctor if irritation becomes severe.

Section 50570-1 (50570-1)

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Acne treatment

Warnings

For external use only.

Directions
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer up to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, use sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient (Active ingredient)

Benzoyl peroxide 10%

Other Information (Other information)
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients (Inactive ingredients)

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, methylparaben, purified water, sodium hydroxide

Questions Or Comments? (Questions or comments?)

866-323-0107 or visit www.natureplex.com

When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Principal Display Panel 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

NDC 67234-035-01

Natureplex

MAXIMUM STRENGTH

ZitFree

Acne Treatment Cream

* Compare to the

active ingredient of

Clearasil ® Daily

Clear ® Vanishing

Acne Treatment Cream

Oil-Free, Odorless Cream Disappears As It Works

NET WT 1 OZ (28g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)