FDA Label for Spotless Regimen For Acne, Blemishes And Breakouts
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTC - WHEN USING
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- ACNE CLEARING TREATMENT
- OTC - STOP USE
- PRINCIPAL DISPLAY PANEL - KIT LABEL
- PRINCIPAL DISPLAY PANEL - ACNE CLEARING TREATMENT TUBE LABEL
- PRINCIPAL DISPLAY PANEL - DAILY ACNE WASH TUBE LABEL
Spotless Regimen For Acne, Blemishes And Breakouts Product Label
The following document was submitted to the FDA by the labeler of this product Rodan & Fields. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Benzoyl Peroxide 5%
Benzoyl Peroxide 2.5%
Purpose
Acne treatment
Acne Treatment
Uses
For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.
For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.
Warnings
For external use only
For external use only
- 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.
Otc - When Using
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.
- 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.
- 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.
When using this product
When using this product
Otc - Do Not Use
Do not use if you
- Have very sensitive skin
- Are sensitive to benzoyl peroxide
- Have very sensitive skin
- Are sensitive to benzoyl peroxide
Do not use if you
Otc - Ask Doctor
Stop and ask a doctor if
- Skin irritation becomes severe.
Otc - 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.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Directions
- Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes. Rinse thoroughly and pat dry. Use once daily and increase to twice daily as tolerated. Wash hands after application to help avoid staining fabrics.
- 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.
- Clean the skin thoroughly before applying this product.
- Dispense 1-2 pumps and 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). This product may bleach hair or dyed fabrics.
Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.
Inactive Ingredients
Water, Polyacrylamide, C13-14 Isoparaffin, Jojoba Esters, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Cocamidopropyl Betaine, Laureth-7, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Sodium Benzoate
Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Glycerin, Butylene Glycol, Vaccinium Angustifolium (Blueberry) Fruit Extract, Sodium Hyaluronate, Polygonum Cuspidatum Root Extract, Bisabolol, Allantoin, Zingiber Officinale (Ginger) Root Extract, Octenidine HCl, Fragrance, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Methacrylate Crosspolymer, Myristyl Alcohol, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Cyclopentasiloxane, Butyl Hydroxycyclohexane Carboxylate, Dimethyl Isosorbide, Carbomer, Polyglyceryl-2 Isostearate, Sorbitan Oleate, Diethylhexyl Sodium Sulfosuccinate, Cetyl Hydroxyethylcellulose, Cyclohexasiloxane, Polysorbate 80, Xanthan Gum, Hydroxyphenyl Propamidobenzoic Acid, Ascorbyl Palmitate, Tocopherol, PCA, Sodium Citrate, Citric Acid, Sodium Hydroxide, Propanediol, Pentylene Glycol, Isohexadecane, Caprylyl Glycol, 1,2-Hexanediol, Decylene Glycol, Hydroxyacetophenone, Propylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Titanium Dioxide (CI 77891), Mica, Tin Oxide, Blue 1 (CI 42090), Red 33 (CI 17200), Violet 2 (CI 60725)
Questions
1-888-995-5656
1-888-995-5656
Acne Clearing Treatment
Drug Facts
Otc - Stop Use
Stop use and ask a doctor if
- Skin irritation becomes severe.
Principal Display Panel - Kit Label
RODAN+FIELDS
SPOTLESS
REGIMEN FOR
ACNE, BLEMISHES
AND BREAKOUTS
DESIGNED FOR
TEENS AND YOUNG ADULTS
Eliminate acne-causing bacteria
Helps clear blackheads, whiteheads
and pimples
Helps prevent new blemishes
from forming
Reduces shine
DEVELOPED BY STANFORD-TRAINED
DERMATOLOGISTS DR.KATIE RODAN
AND DR.KATHY FIELDS
Daily Acne Wash
125 mL/4.2 Fl. Oz. U.S.
Acne Clearing Treatment
50 mL/1.7 Fl. Oz. U.S.
Principal Display Panel - Acne Clearing Treatment Tube Label
RODAN+FIELDS
SPOTLESS
ACNE
CLEARING
TREATMENT
2
Principal Display Panel - Daily Acne Wash Tube Label
RODAN+FIELDS
SPOTLESS
DAILY
ACNE
WASH
1
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