FDA Label for Spotless Acne Clearing Treatment
View Indications, Usage & Precautions
Spotless Acne Clearing Treatment 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 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
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.
When using this product
Otc - Stop Use
Stop and ask a doctor
- If skin irritation becomes severe.
Otc - Do Not Use
Do not use if you
- Have very sensitive skin.
- Are sensitive to benzoyl peroxide.
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.
Directions
- 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.
Inactive Ingredients
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 lsosorbide, Carbomer, Polyglyceryl-2 lsostearate, Sorbitan Oleate, Diethylhexyl Sodium Sulfosuccinate, Cetyl Hydroxyethylcellulose, Cyclohexasiloxane, Polysorbate 80, Xanthan Gum, Hydroxyphenyl Propamidobenzoic Acid, Ascorbyl PaImitate, Tocopherol, PCA, Sodium Citrate, Citric Acid, Sodium Hydroxide, Propanediol, Pentylene Glycol, lsohexadecane, Caprylyl Glycol, 1,2-Hexanediol, Decylene Glycol, Hydroxyacetophenone, Propylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Titanium Dioxide (Cl 77891), Mica, Tin Oxide, Blue 1 (Cl 42090), Red 33 (Cl 17200), Violet 2 (Cl 60725)
Questions
1-888-995-5656
Principal Display Panel - 50 Ml Carton Label
RODAN+FIELDS
SPOTLESS
ACNE
CLEARING
TREATMENT
2
50 mL/1.7 Fl. Oz. U.S.
Principal Display Panel - 50 Ml Tube Label
RODAN+FIELDS
SPOTLESS
ACNE
CLEARING
TREATMENT
2
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