Xtracare Deep Cleaning Astringent Gel
FDA Label NDC 57337-035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International for the product Xtracare Deep Cleaning Astringent (NDC 57337-035). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                          Purpose

Salicylic Acid 2% ................ Acne Medication

Otc - Purpose

XtraCare (salicylic acid) deep cleaning astringent

  • cleans deep
  • treats acne
  • helps prevent pimples

    • Compare to Clean & Clear® Deep Cleaning Astringent

    8 fl. oz. (237 mL)

    salicylic acid deep cleaning astringent

Otc - Keep Out Of Reach Of Children

keep out of reach of children

Indications & Usage

Use  for the treatment of acne

Warnings

Warnings For external use only

Flammable, keep away from open flame

When using this product

  • avoid contact with eyes. If contact occurs, immediately flush with water.
  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Dosage & Administration

Directions

  • cleanse the skin thoroughly before applying medication
  • moisten a cotton ball or pad cover the entire
  • affected rea with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a physician. If bothersome drying or peeking occurs, reduce application to once a day or every other day.

Inactive Ingredient

Inactive Ingredients

water, alcohol, PEG-40 hydrogenated castor oil, fragrance, aloe barbadensis leaf juice, d&c red no.33

Other Safety Information

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®deep cleansing astringent.

DISTRIBUTED BY: 

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA

* Please review the disclaimer below.