Rodan + Fields Unblemish

Rodan + Fields Unblemish
SPL v1
SPL
SPL Set ID f1c67c7f-0071-4b12-b50d-534839a8d01a
Route
TOPICAL
Published
Effective Date 2014-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Benzyl Alcohol Biosaccharide Gum-1 Carbomer 934 C13-14 Isoparaffin Ceramide 6 Ii Ceramide 1 Ceramide 3 Chamomile Cholesterol Edetate Disodium Disodium Oleamido Mea-sulfosuccinate Glycerin Laureth-7 Niacinamide Panthenol Phytosphingosine Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Punica Granatum Root Bark Water Sodium Lauroyl Lactylate Xanthan Gum Yucca Glauca Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-01

Description

Benzoyl Peroxide 5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl Peroxide 5%

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.
Section 50566-9

Stop use and ask a doctor if irritation becomes severe.

Warnings

​For external use only.

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.
Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Do Not Use If You
  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.
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

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.
Keep Out of Reach of Children.

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

Principal Display Panel Rodan+fields

Rodan+Fields

Unblemish

Dual Intensive Acne Treatment

2 X 22.5 mL/0.76 Fl. Oz.


Structured Label Content

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.
Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation becomes severe.

Purpose

Acne treatment

Warnings

​For external use only.

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.
Drug Facts

Active Ingredient (Active ingredient)

Benzoyl Peroxide 5%

Do Not Use If You (Do not use if you)
  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.
Other Information (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 (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

When Using This Product (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.
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.

Principal Display Panel Rodan+fields (Principal Display Panel - Rodan+Fields)

Rodan+Fields

Unblemish

Dual Intensive Acne Treatment

2 X 22.5 mL/0.76 Fl. Oz.


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