Label: UNBLEM EST- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42265-101-12 - Packager: Elli Est
- 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 September 21, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNBLEM EST
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42265-101 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 WATER (UNII: 059QF0KO0R) 840 mg in 1 g POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) 30 mg in 1 g C13-14 ISOPARAFFIN (UNII: E4F12ROE70) 15 mg in 1 g Laureth-7 (UNII: Z95S6G8201) 10 mg in 1 g Methylparaben (UNII: A2I8C7HI9T) 2.5 mg in 1 g Propylparaben (UNII: Z8IX2SC1OH) 2.5 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42265-101-12 28 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/25/2012 Labeler - Elli Est (968164066) Establishment Name Address ID/FEI Business Operations Elli Est 968164066 manufacture(42265-101) , label(42265-101)
