SIGNATURE CARE MEDICATED COOLING- witch hazel cloth

Signature Care Medicated Cooling by

Drug Labeling and Warnings

Signature Care Medicated Cooling by is a Otc medication manufactured, distributed, or labeled by Better Living Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                          Purpose

Witch hazel 50%.........................................Astringent

PURPOSE

Uses

• temporarily relieves the local itching and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas
• temporarily relieves irritation and burning

WARNINGS

Warnings For external use only.

WHEN USING

When using this product

• do not use more than directed unless told to do so by a doctor
• do not put directl in rectum by using fingersd or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

Adults:

• when practical clean the affected area with mild soap and warm water, and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply externally to the affected area up to 6 times daily or after each bowel movement
• after application, discard pad

 Children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information store at 68° to 77°C (20° to 25°F)

INACTIVE INGREDIENT

Inactive ingredients alcohol, citric acid, diazol glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

DOSAGE & ADMINISTRATION

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

MADE IN CHINA

QUALITY & SATISFACTION 100% GUARANTEED

OR YOUR MONEY BACK

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE MEDICATED COOLING 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-928
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-928-00	100 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	10/03/2016

Labeler - Better Living Brands, LLC (009137209)