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Spotless daily acne wash - Medication Information

Product NDC Code 14222-1610
Drug Name

Spotless daily acne wash

Type Brand
Active Ingredients
Benzoyl peroxide .05 g/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 308696
Application Number M006
Labeler Name Rodan & Fields
Packages
Package NDC Code Description
14222-1610-1 1 tube in 1 carton (14222-1610-1) / 125 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Benzoyl Peroxide 5 %

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Polyacrylamide, C13-14 lsoparaffin, Jojoba Esters, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Cocamidopropyl Betaine, Laureth-7, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Sodium Benzoate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Purpose

Information about the drug product’s indications for use.
Purpose Acne treatment

Spl product data elements

Usually a list of ingredients in a drug product.
SPOTLESS Daily Acne Wash Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN CARBOXYPOLYMETHYLENE COCAMIDOPROPYL BETAINE DOCUSATE SODIUM ETHYLHEXYLGLYCERIN HYDROGENATED JOJOBA OIL, RANDOMIZED LAURETH-7 PHENOXYETHANOL PROPANEDIOL SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SODIUM HYDROXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel - 125 mL Carton Label RODAN+FIELDS SPOTLESS DAILY ACNE WASH 1 125 mL/4.2 Fl. Oz. U.S. Principal Display Panel - 125 mL Carton Label Principal Display Panel - 125 mL Tube Label RODAN+FIELDS SPOTLESS DAILY ACNE WASH 1 Principal Display Panel - 125 mL Tube Label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you Have very sensitive skin. Are sensitive to benzoyl peroxide.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions 1-888-995 - 5656

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop and ask a doctor If skin irritation becomes severe.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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. 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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 and ask a doctor If skin irritation becomes severe. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API