FDA Label for Zitfree Acne Treatment
View Indications, Usage & Precautions
Zitfree Acne Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Natureplex Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
Otc - Do Not Use
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.
Otc - Stop Use
Stop use and consult a doctor if irritation becomes severe.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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)
* Please review the disclaimer below.