Image Clear Cell Acne Spot Treatment Gel
FDA Label NDC 60232-5022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Image Clear Cell Acne Spot Treatment (NDC 60232-5022). 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 warnings, active ingredients, purpose, use, directions, keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

For external use only.  Do not use if you have very sensitive skin.  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.  Stop use and ask a doctor if irritation becomes severe.  If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Salicylic Acid 2%

Purpose

Acne treatment

Use

For the treatment of acne

Directions

Clean the skin thoroughly before applying this product.  Cover the entire affected area with a thin layer one to three times daily.  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 peelig occurs, reduce application to once a day or every other day. 

Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated above.

Keep Out Of Reach Of Children

Keep out of reach of children

Other Information

Store at room temperature

Inactive Ingredients

water, propanediol, butylene glycol, polyacrylate crosspolymer-6, glycerin, dimethyl isosorbide, zinc PCA, melaleuca alfernifolia (tea tree) leaf oil, tasmannia lanceolata fruit/leaf extract, zingiber officinale (ginger) root extract, cinnamomum cassia bark extract, sanguisorba officinalis root extract, laminaria digitata extract, chlorella vulgaris extract, saccharide isomerate, terpineol, alpha-terpinene, trpinolene, pinene, maris aqua, ethylhexylgylcerin, sodium hdyroxide, phenoxyethanol

Questions

Questions? Call 800-796-7546

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