QC MEDICATED COOLING- witch hazel cloth

QC Medicated Cooling by

Drug Labeling and Warnings

QC Medicated Cooling by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Witch Hazel 50%..........................................................Anorectal/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 directly in the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and older:
• 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 soft cloth before applying
• DO NOT FLUSH - after application, discard pad in trash and wash hands
• apply to the affected area up to 6 times daily or after each bowel movement
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)
• protect from excessive heat

INACTIVE INGREDIENT

Inactive ingredient

alcohol, citric acid, dizaolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

DOSAGE & ADMINISTRATION

Distributed by: CDMA, Inc.

Novi, MI 48375

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QC MEDICATED COOLING 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-311
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-311-01	1 in 1 CARTON	10/30/2024
1		100 in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/30/2024

Labeler - Chain Drug Marketing Association, Inc. (011920774)