Targeted Acne Spot Treatment
FDA Label NDC 69842-181

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Targeted Acne Spot Treatment (NDC 69842-181). 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, do not use if you have, stop use and ask a doctor if, keep out of reach of children., when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl peroxide 2.5%

Purpose

Acne Treatment

Uses

Treats and helps prevent new acne blemishes.

Warnings

For external use only.

Do Not Use If You Have

very sensitive skin or if you are sensitive to benzoyl peroxide.

Stop Use And Ask A Doctor If

irritation becomes severe and continues.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison COntrol Center right away.

When Using This Product

  • avoid unnecessary sun exposure and use a sunscreen
  • using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin. If this occurs, only one drug should be used.
  • keep away from eyes, lips, mouth
  • this product may bleach hair or dyed fabrics

Directions

Cleanse skin thoroughly before applying. COver entire affected area with a thin layer 1 to 3 times daily. Start with one application daily, because excessive drying may occur. Then gradually increase to 2 to 3 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 outsie use a sunscreen. Allow acne medication to dry before application of sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

  • Keep tightly closed
  • Avoid storing at extreme temperatures (below 40 F and above 100 F).

Inactive Ingredients

Water, Bentonite, Caprylic/Capric Triglyceride, Glycerin, Emulsifying Wax NF, Polysorbate 20, Glyceryl Laurate, Cetyl Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Citrate, Disodium EDTA, Citric Acid, Methylparaben, Propylparaben.

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