Otc - Active Ingredient
Active Ingredients Purpose
Witch Hazel 50%..........................................................Anorectal/Astringent
Qc Medicated Cooling Cloth
FDA Label NDC 83324-311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Qc Medicated Cooling (NDC 83324-311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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
Otc - 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
Otc - 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
Package Label.Principal Display Panel
99619 (99619.2)
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