UNBLEMISH- benzoyl peroxide lotion

Unblemish by

Drug Labeling and Warnings

Unblemish by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne treatment

Uses

• For the treatment of acne.
• Penetrates pores to control acne blemishes, pimples and blackheads.
• Helps prevent new acne blemishes, pimples and blackheads from forming.

Warnings

​For external use only.

Do not use if you

• Have very sensitive skin.
• Are sensitive to benzoyl peroxide.

When using this product

• Skin irritation and dryness are 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 combination.

STOP USE

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Cleanse skin thoroughly before applying this product.
• Dispense 1-2 pumps from each side.  Blend product and apply evenly over the entire face, avoiding the eye area.  Allow to penetrate skin.  Do not rinse off.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily as needed or as directed by a doctor.  If bothersome dryness or peeling occur reduce application to once a day or every other day and apply a moisturizer.
• If going outside, apply sunscreen after using this product.  If irritation or sensitivity develop, stop use of both products and ask a doctor.

Other information

You may report a serious adverse reaction to Rodan+Field​s®​, Attn: Product Development, 60 Spear Street, Suite 600, San Francisco, CA 94105.

Inactive ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Biosaccharide Gum-1, Carbomer, C13-14 Isoparaffin, Ceramide AP, Ceramide EOP, Ceramide NP, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Disodium EDTA, Disodium Oleamido MEA Sulfosuccinate, Glycerin, Laureth-7, Niacinamide, Panthenol, Phytosphingosine, Polyacrylamide, Punica Granatum Extract, Purified Water, Sodium Lauroyl Lactylate, Xanthan Gum, Yucca Glauca Root Extract

Principal Display Panel - Rodan+Fields

Rodan+Fields

Unblemish

Dual Intensive Acne Treatment

2 X 22.5 mL/0.76 Fl. Oz.

INGREDIENTS AND APPEARANCE

UNBLEMISH 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CARBOMER 934 (UNII: Z135WT9208)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CHAMOMILE (UNII: FGL3685T2X)
CHOLESTEROL (UNII: 97C5T2UQ7J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-7 (UNII: Z95S6G8201)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
XANTHAN GUM (UNII: TTV12P4NEE)
YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2000-2	1 in 1 CARTON
1		22.5 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/01/2014

Labeler - Rodan & Fields, LLC (051659584)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	manufacture(14222-2000) , analysis(14222-2000) , label(14222-2000)