Otc - Active Ingredient
Active Ingredients: Benzoyl Peroxide 10%
Unblem Est
FDA Label NDC 42265-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elli Est for the product Unblem Est (NDC 42265-101). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Acne Treatment
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: if
swallowed, get medical help or contact
a poison control center right away
Indications & Usage
Usage: For external use only.
Do not use if: you have very sensitive
skin are sensitive to benzoyl peroxide.
Warnings
Warning: For external use only.
Do not use if you- have very sensitive skin-are sensitive to benzoyl peroxide.
Keep 0ut of reach of children. If swallowed, get medical help or contact a poison control center right away.
When using this product -keep away from eyes, lips and mouth.-
If contact occurs, flush thoroughly with water.- If going outside apply sunscreen after using this product.
-If irritation or sensitivity develops, stop use of both products and ask a doctor.
Avoid contact with hair or dyed fabric,including carpet and clothing which may be bleached by this product.
-skin irritation may occur ,characterized by redness, burning , itching, peeling or possibly swelling.
Mild irritation may be reduced by using the product less frequently or in a lower concentration. -If irritation becomes sever, discontinue use.
If irritation still continues ,consult a doctor.
-Using other topical acne medication at the same time or immediately following the 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
Dosage & Administration
Directions: Cleanse the skin thoroughly before applying medication.- Cover the entire affected area with a thin layer 1 to 3 times daily.
-If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Because of excessive drying of the skin may occur start with one application daily, then gradually increase to two or three times daily if needed or as
directed by a doctor.
Inactive Ingredient
Inactive Ingredients: Water (Aqua), Polyacrylamide crosslinked 0.01-0.2 mole percent bisacrlyamid
C-13-14 Isoparafin, laureth-7, Methylparaben, Propylparaben.
Package Label.Principal Display Panel
Elli'Est
Unblem'Est
Medicated Clarifying Lotion
With 10% Benzoyl Peroxide
1oz. / 28g.
Ndc42265-101-12 (42265 101 12)
ndc42265-101-12
label image
bpo1
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