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ZITFREE ACNE TREATMENT

Dosage form: ointment
Ingredients: BENZOYL PEROXIDE 100mg in 1g
Labeler: Natureplex LLC
NDC Code: 67234-035

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ZITFREE
ACNE TREATMENT

Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

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

Warnings

For external use only.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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.

Stop use and consult a doctor if irritation becomes severe.

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

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.

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.

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

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)

ZITFREE   ACNE TREATMENT
benzoyl peroxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
HYPROMELLOSE, UNSPECIFIED 
LAURETH-4 
METHYLPARABEN 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:67234-035-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/2014
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex LLC062808196MANUFACTURE(67234-035)

Revised: 12/2017
 
Natureplex LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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