THERA WISE NATURAL ACNE- salicylic acid ointment

Thera Wise Natural Acne by

Drug Labeling and Warnings

Thera Wise Natural Acne by is a Otc medication manufactured, distributed, or labeled by Derma Wise Skin Care Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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 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?

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)

INGREDIENTS AND APPEARANCE

THERA WISE NATURAL ACNE 
salicylic acid ointment

Product 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)
Thioctic 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)