Thera Wise Natural Acne
FDA Label NDC 43347-189

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma Wise Skin Care Ltd. for the product Thera Wise Natural Acne (NDC 43347-189). 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, use, warnings, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Astringent/Anti-inflammatory

Use

Helps treat acne pimples and allows skin to heal

Warnings

For external use only.

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.
  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Directions

  • See warnings under "When using this product".
  • Cleanse skin thoroughly before applying the product.
  • Apply product to affected areas one to three times daily or as directed by a health care practitioner.

Other Information

Store at 2°- 25° C (35°- 77° F)

Inactive Ingredients

Aloe Leaf Extract

Certified Organic

, Alpha Glucan Oligosaccharide, Alpha Lipoic Acid, Cetearyl Olivate, Dehydroacetic Acid, Denatured Alcohol, Marine Algae Extract, Oat Beta-Glucan, Olive Squalane Peppermint Oil, Rose Hip Seed Oil, Sclerotium Gum, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Tamanu Oil, Tapioca Starch, Tea Tree Oil, Tocopherols, Water, Witch Hazel Extract.

Questions Or Comments?

Call weekdays 9am to 5pm PST @ 1.888.488.1808

Principal Display Panel - 28 G Tube Box

THÉRA WISE®

Natural Acne Treatment
SALICYLIC ACID, 0.5 %
Clears acne blemishes without over drying
Prevents new acne from forming

WITH TAMANU OIL, OAT PREBIOTICS, ALOE VERA
LEAF EXTRACT, ROSEHIP SEED OIL, WILLOW
& WITCH HAZEL BARK EXTRACTS

NET WT 1OZ (28g)

Principal Display Panel (28 g Tube Box)

Principal Display Panel (28 g Tube Box)

* Please review the disclaimer below.