SIGNATURE CARE MEDICATED WIPES HEMORRHOIDAL WIPES WITH WITCH HAZEL- hemorrhoidal wipes with witch hazel cloth

Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel by

Drug Labeling and Warnings

Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel by is a Otc medication manufactured, distributed, or labeled by Better Living Brands LLC, Nice-Pak Products , Inc., Nice-Pak Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Witch hazel 50%

PURPOSE

Astringent

USES

helps relieve the local itching and discomfort associated with hemorrhoids

temporary relief of irritation and burning

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

STOP USE AND ASK A DOCTOR IF

bleeding occurs

condition worsens or does not improve within 7 days

DIRECTIONS

adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area

use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard

children under 12 years of age: consult a doctor

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENTS

2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium Cocoamphodiacetate, Glycerin, Iodopropynyl Butylcarbamate, PEG-75 Lanolin, Propylene Glycol, Sodium Citrate, Water

Other Uses

for vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.

for use as a moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

FOR COMMENTS OR QUESTIONS PLEASE

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL - LID LABEL

Signature Care

Quality Guaranteed

Compare to the active ingredient in Preparation H(R) Medicated Wipes*

MEDICATED WIPES

HEMORRHOIDAL WIPES WITH WITCH HAZEL

Mild, everyday wipes to ease & lessen irritation

Soothing; Gentle; Soft

Convenient; Easy to use

For hemorrhoidal & vaginal care

WITH ALOE TO SOOTHE

48 MEDICATED WIPES

5 in X 6 in (12.7 cm x 15.2 cm)

2OA9131SLI

INGREDIENTS AND APPEARANCE

SIGNATURE CARE MEDICATED WIPES HEMORRHOIDAL WIPES WITH WITCH HAZEL 
hemorrhoidal wipes with witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BRONOPOL (UNII: 6PU1E16C9W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
PEG-75 LANOLIN (UNII: 09179OX7TB)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-800-48	48 in 1 CONTAINER	08/28/2020
1		252 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	08/28/2020

Labeler - Better Living Brands LLC (009137209)

Registrant - Nice-Pak Products , Inc. (003778198)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, Inc.		067900167	manufacture(21130-800)