ZITFREE  ACNE TREATMENT- benzoyl peroxide ointment 
Natureplex LLC

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.

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ZITFREE
ACNE TREATMENT

Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

Uses

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

Other information

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)

Principal Display Panel - 28 g Tube Carton
ZITFREE   ACNE TREATMENT
benzoyl peroxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LAURETH-4 (UNII: 6HQ855798J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-035-011 in 1 CARTON12/01/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/2014
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-035)

Revised: 12/2017
Document Id: 94b69547-fb1d-4591-9e38-451521fbf64b
Set id: 70c2e3fb-e643-467b-80fd-c40e3c3e9513
Version: 2
Effective Time: 20171204
 
Natureplex LLC