Spotless Acne Clearing Treatment Lotion
FDA Label NDC 14222-1620

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 Acne Clearing Treatment (NDC 14222-1620). 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 - stop use, otc - do not use, 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 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.
  • 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 - 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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