WIPEGEL- witch hazel gel

WIPEGEL by

Drug Labeling and Warnings

WIPEGEL by is a Otc medication manufactured, distributed, or labeled by ZERO TABOOS LLC, Private Label Partners, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

WITCH HAZEL 30%

PURPOSE

ASTRINGENT

USES

• AIDS IN PROTECTING IRRITATED ANORECTAL AREAS.

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT:

• Do not exceed the recommended daily dosage unless directed by a doctor.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.
• Do not use as a leave-on gel or for a compress.
• Do not use on open wounds.

Stop use and ask a doctor if:
Bleeding occurs.
Condition worsens or does not improve within 7 days.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults:
Add a drop of Wipegel on toilet paper.
Cleanse perineum area by gently wiping, patting or blotting.
Use up to 6 times daily or after each bowel movement.

Children under 12 years of age, consult a doctor.

OTHER INFORMATION

• store at 20-25 C (68-77 F)
• protect from direct sun exposure.

INACTIVE INGREDIENTS

Aqua, Carbomer, Inulin Alpha-glucan oligosaccharide (prebiotic blend), Fragrance (natural preservative), Sodium Hydroxide.

QUESTIONS

For questions and comments please go to: www.zerotaboos.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WIPEGEL 
witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72294-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
INULIN (UNII: JOS53KRJ01)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72294-101-11	240 g in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/16/2018

Labeler - ZERO TABOOS LLC (081177168)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Partners, Inc.		046033481	manufacture(72294-101)