Label: THERA WISE NATURAL ACNE- salicylic acid ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 43347-189-01 - Packager: Derma Wise Skin Care Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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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.
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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
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Inactive ingredients
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
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- PRINCIPAL DISPLAY PANEL - 28 g Tube Box
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INGREDIENTS AND APPEARANCE
THERA WISE NATURAL ACNE
salicylic acid ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43347-189 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 0.14 g in 28 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) .Alpha.-Glucan Oligosaccharide (UNII: S95658MI3W) ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) Alcohol (UNII: 3K9958V90M) Squalane (UNII: GW89575KF9) Peppermint Oil (UNII: AV092KU4JH) Rosa Moschata Oil (UNII: J99W255AWF) Betasizofiran (UNII: 2X51AD1X3T) Sodium Anisate (UNII: F9WFJ28MV9) Sodium Levulinate (UNII: VK44E1MQU8) Sorbitan Olivate (UNII: MDL271E3GR) Tamanu Oil (UNII: JT3LVK84A1) Starch, Tapioca (UNII: 24SC3U704I) Tea Tree Oil (UNII: VIF565UC2G) Tocopherol (UNII: R0ZB2556P8) Water (UNII: 059QF0KO0R) Hamamelis Virginiana Top (UNII: UDA30A2JJY) Nori (UNII: 477TV3P5UX) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43347-189-01 1 in 1 BOX 08/15/2016 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 08/15/2016 Labeler - Derma Wise Skin Care Ltd. (242166531)