Assured Acne Cream
FDA Label NDC 35038-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hangzhou Mino Daily Chemicals Co.ltd. for the product Assured Acne Cream (NDC 35038-200). 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 other, active ingredient, purpose, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - keep out of reach of children, use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

Active Ingredient

Salicylic Acid  0.5%

Purpose


Acne Treatment

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you have deep puncture wounds or serious burns

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Otc - When Using

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

    • When using this product, avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

Otc - Stop Use

Stop use and ask a doctor if condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Use

for the treatment of acne.

Warnings

For external use only.

Otc - Do Not Use

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid.

Directions

Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. 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 occurs, reduce application to once a day.

Other Information

store between 20 to 25 C (66 to 77 F)

Inactive Ingredients

carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water.

Package Label

Acne Cream (Acnecream)

Acne Cream (Acnecream)

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