THERA WISE NATURAL HEMORRHOIDAL- witch hazel ointment

Thera Wise Natural Hemorrhoidal by

Drug Labeling and Warnings

Thera Wise Natural Hemorrhoidal 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

Witch Hazel 12%

Purpose

Astringent / Anti-inflammatory

Uses

• For the temporary relief of anorectal discomfort associated with hemorrhoids
• For the temporary relief of local itching associated with hemorrhoids

Warnings

For rectal and external use only

Allergy alert: contains Asteracea (daisy) plant material

Do not use this product with the applicator if the introduction of the applicator into the rectum causes additional pain.

Consult a doctor promptly.

Stop use and consult a doctor if:

• Condition worsens or does not improve within 7 days
• Bleeding occurs

When using this product do not exceed the recommended daily dosage unless directed by your doctor.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

• When first opening, tear away safety seal.
• Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / or
• pat and blot with appropriate cleansing pad.
• Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.
• FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube.
• Lubricate applicator well, then gently insert applicator into the rectum.
• Thoroughly cleanse applicator after each use and replace cover.
• Apply to the affected area up to 6 times daily or after each bowel movement.
• Children under 12 years of age: consult a doctor.

Other information

• Store between 2° and 25° C (35° - 77° F)
• Do not use if seal is broken

Inactive ingredients

Aloe Vera Extract1, Argan Kernel Oil, Butcher's Broom Extract, Cetearyl Olivate, Chamomile Flower Extract1, Citric Acid, Dehydroacetic Acid, Glycerin, Grape Seed Oil, Hydrogenated Olive Oil, Oat Beta Glucan, Olive Oil, Olive Oil Unsaponifiables Olive Squalane, Seabuckthorn Fruit Oil, Sclerotium Gum, Shea Butter, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Sodium Steroyl Glutamate, Stearyl Alcohol, Sunflower Seed Oil, Tocopherols, Water

1 Certified Organic

Questions or Comments?

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PRINCIPAL DISPLAY PANEL - 28 g Tube Box

Natural Hemorrhoidal Ointment

12 % WITCH HAZEL
For the temporary relief of itching and
discomfort associated with hemorrhoids

THÉRA WISE®

WITH BUTCHER'S BROOM, WITCH HAZEL, CHAMOMILE
& ALOE LEAF EXTRACT, OAT PREBIOTIC,
GRAPE SEED, SEABUCKTHORN & ARGAN OIL

NEW WT 1OZ (28g)

INGREDIENTS AND APPEARANCE

THERA WISE NATURAL HEMORRHOIDAL 
witch hazel ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43347-158
Route of Administration	TOPICAL, RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)	Witch Hazel	3.36 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Ruscus Aculeatus Root (UNII: ZW12V95I1Q)
Cetearyl Olivate (UNII: 58B69Q84JO)
Chamaemelum Nobile Flower (UNII: O2T154T6OG)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Dehydroacetic acid (UNII: 2KAG279R6R)
Glycerin (UNII: PDC6A3C0OX)
Grape Seed Oil (UNII: 930MLC8XGG)
Hydrogenated Olive Oil (UNII: 53839415GI)
Olive Oil (UNII: 6UYK2W1W1E)
Olea Europaea (Olive) Oil Unsaponifiables (UNII: XO45V955LT)
Squalane (UNII: GW89575KF9)
Betasizofiran (UNII: 2X51AD1X3T)
Shea Butter (UNII: K49155WL9Y)
Sodium Anisate (UNII: F9WFJ28MV9)
Sodium Levulinate (UNII: VK44E1MQU8)
Sorbitan Olivate (UNII: MDL271E3GR)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Sunflower Oil (UNII: 3W1JG795YI)
Tocopherol (UNII: R0ZB2556P8)
Glucosyl Hesperidin (UNII: 432C95B6YE)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43347-158-01	1 in 1 BOX	08/15/2016
1		28 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/15/2016

Labeler - Derma Wise Skin Care Ltd. (242166531)