Label: ZITFREE ACNE TREATMENT- benzoyl peroxide ointment
- NDC Code(s): 67234-035-01
- Packager: Natureplex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 4, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
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.
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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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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INGREDIENTS AND APPEARANCE
ZITFREE ACNE TREATMENT
benzoyl peroxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-035-01 1 in 1 CARTON 12/01/2014 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 12/01/2014 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-035)
