UNBLEM EST - benzoyl peroxide cream 
Elli Est

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.

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Active Ingredients: Benzoyl Peroxide 10%

Purpose: Acne Treatment

Keep out of reach of children: if
swallowed, get medical help or contact
a poison control center right away

Usage: For external use only.
Do not use if: you have very sensitive
skin are sensitive to benzoyl peroxide.

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

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 Ingredients: Water (Aqua), Polyacrylamide crosslinked 0.01-0.2 mole percent bisacrlyamid
C-13-14 Isoparafin, laureth-7, Methylparaben, Propylparaben.

Elli'Est
Unblem'Est
Medicated Clarifying Lotion
With 10% Benzoyl Peroxide
1oz. / 28g.

ndc42265-101-12

ndc42265-101-12
label image
bpo1

UNBLEM EST 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42265-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42265-101-1228 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/25/2012
Labeler - Elli Est (968164066)
Establishment
NameAddressID/FEIBusiness Operations
Elli Est968164066manufacture(42265-101) , label(42265-101)

Revised: 9/2012
Document Id: 264fab26-2c13-422e-9395-23029b2d0b82
Set id: 3f0f7047-c1cf-4407-a1ff-26d9f5c8a05c
Version: 8
Effective Time: 20120921
 
Elli Est