Spotless 30-day Regimen Kit
FDA Label NDC 14222-1602

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rodan & Fields for the product Spotless 30-day Regimen (NDC 14222-1602). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - when using, otc - do not use, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.
  • 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.
    • 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.

Otc - Do Not Use

Do not use if you

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
  • Do not use if you

    • Have very sensitive skin
    • Are sensitive to benzoyl peroxide

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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