Other
Acne Treatment Lotion
Medicated Wash
Acne Treatment System Kit
FDA Label NDC 67226-3026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivier Pharma, Inc. for the product Acne Treatment System (NDC 67226-3026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings for exrernal use only, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzoyl Peroxide USP 5%
Salicylic Acid USP 2%
Purpose
Acne Treatment
Acne Treatment
Use
For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackhead and white heads.
Warnings For Exrernal Use Only
Ask a doctor before use if you are
Using other topical acne medications at the
same time or immediately following use of
this product may increase dryness or
irritation of the skin. If this occurs, only one
medication should be used unless directed
by a doctor
Do not use if you
Have very sensitive skin
are sensitive to Benzoyl Peroxide
When using this product
Avoid Unnecessary sun exposure and use a sunscreen
Avoid contact with 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 ny using the product less frequesntly or in lower concentration.
Stop use and ask a doctor if
Irritation becomes severe.
Ask a doctor before use if you are
Using other topical acne medications at the
same time or immediately following use of
this product may increase dryness or
irritation of the skin. If this occurs, only one
medication should be used unless directed
by a doctor
When using this product
Do not get into eyes.
Stop use and ask a doctor if
Excessive skin irritation develops or increases.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
Wash hands with a non-medicated soap (contains no Benzoyl Peroxide).
Cleanse and dry face thoroughly 5 minutes before use.
Using fingertips, apply evenly to affected areas.
Use both morning and night or as directedby a physician.
If dryness or peeling occurs, reduce application to once a day or every other day.
Fair skinned individuals should begin with one application.
For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a healthcare practitioner.
Wet face using lukewarm water.
Gently massage over the face using fingertips.
Rinse completely.
Use both morning and night or as directed by a physician.
If dryness or peeling occurs, reduce application to once a day or every other day.
Other Information
Store at room tempreture
(15-30°C / 59-86°F).
Inactive Ingredients
C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.
Acrylates Copolymer, Alcohol, Citric Acid, Disodium
Cocoamphodiacetate, Disodium Cocoyl Glutamate,
DMDM Hydantoin, Ethoxydiglycol, Fragrance,
Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate,
PEG-120 Methyl Glucose Dioleate, Sodium
Hydroxide, Sodium Lauroyl Sarcosinate, Water / Eau.
Uses
For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackhead and white heads.
* Please review the disclaimer below.
