UNBLEMISH DUAL INTENSIVE ACNE TREATMENT- benzoyl peroxide lotion

UNBLEMISH Dual Intensive Acne Treatment by

Drug Labeling and Warnings

UNBLEMISH Dual Intensive Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzoyl Peroxide 2.5%

Purpose

Acne treatment

Uses

• For the treatment of acne.
• Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Warnings

For external use only

When using this product

• Skin irritation and dryness is 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.

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 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 concentration.

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

• Clean the skin thoroughly before applying this product. Dispense 1-2 pumps from each side. Blend product evenly. Cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face.
• Because 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.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• Wash hands after application to help avoid staining fabrics.

Other Information

Store between 15-30°C (59-86°F).

Inactive Ingredients

Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MIPA-Sulfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, Cl3-14 lsoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool

Questions

1-888-995-5656

Principal Display Panel - 45mL / 1.5 Fl. Oz. Carton Label

RODAN+FIELDS

UMBLEMISH

3 Dual Intensive
Acne Treatment

RODAN+FIELDS

2 x 22.5 mL/0.76 Fl. Oz. U.S.

Principal Display Panel - 45mL / 1.5 Fl. Oz. Tube Label

RODAN+FIELDS

UMBLEMISH

3 Dual Intensive
Acne Treatment

INGREDIENTS AND APPEARANCE

UNBLEMISH DUAL INTENSIVE ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	0.025 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GERANIOL (UNII: L837108USY)
LAURETH-7 (UNII: Z95S6G8201)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POMEGRANATE (UNII: 56687D1Z4D)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
STARCH, CORN (UNII: O8232NY3SJ)
XANTHAN GUM (UNII: TTV12P4NEE)
YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2120-1	1 in 1 CARTON	02/13/2019
1		45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/13/2019

Labeler - Rodan & Fields (051659584)