Thera Wise Natural Acne

Manufacturer
Derma Wise Skin Care Ltd.
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:21

Label at a glance#

ProductThera Wise Natural Acne
Active ingredientSalicylic Acid
Label structure10 sections

Dosage and administration

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.

Storage and handling

Store at 2°- 25° C (35°- 77° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Astringent/Anti-inflammatory

Use

INDICATIONS & USAGE SECTION

Helps treat acne pimples and allows skin to heal

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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 SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

Store at 2°- 25° C (35°- 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Leaf Extract1, Alpha Glucan Oligosaccharide, Alpha Lipoic Acid, Cetearyl Olivate, Dehydroacetic Acid, Denatured Alcohol, Marine Algae Extract, Oat Beta-Glucan, Olive Squalane Peppermint Oil1, Rose Hip Seed Oil1, Sclerotium Gum, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Tamanu Oil1, Tapioca Starch1, Tea Tree Oil, Tocopherols, Water, Witch Hazel Extract.

1 Certified Organic

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays 9am to 5pm PST @ 1.888.488.1808

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804844salicylic acid 0.5 % Topical OintmentPSN3
1804844salicylic acid 0.005 MG/MG Topical OintmentSCD3
1804844salicylic acid 0.5 % Topical OintmentSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43347-189-012024-01-30C16284748780-11030e365-3ba8-111a-e063-dadaa90a10e2Théra Wise ® Natural Acne

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43347-189-01Thera Wise Natural Acne1 in 1 BOXOINTMENT13
43347-189-01Thera Wise Natural Acne28 g in 1 TUBEOINTMENT283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43347-189THERA WISE NATURAL ACNE (SALICYLIC ACID) OINTMENT [DERMA WISE SKIN CARE LTD.]3Legacy NDC, 2 package rows20220121_badcc3ef-d124-4f03-af61-362d9f64ef95.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43347-18943347-189-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9d615145-d202-4142-afc6-5c965864dfbebadcc3ef-d124-4f03-af61-362d9f64ef952022-01-19WarningsExact identifier
spl id: 9d615145-d202-4142-afc6-5c965864dfbe
spl set id: badcc3ef-d124-4f03-af61-362d9f64ef95

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.