Otc - Active Ingredient
Active Ingredient Purpos
Menthol 10.5% Topical Analgesic
C.d.m.a Icy Cool
FDA Label NDC 52313-1131
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sklar Bov Solutions Inc for the product C.d.m.a Icy Cool (NDC 52313-1131). 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, indications & usage, warnings, warnings and precautions, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses - Topical Analgesic
Indications & Usage
INDICATIONS AND USAGE
Temporary relief form minor aches and pains of sore muscles and joints associated with arthritis backache, strains and sprains
Warnings
Warning
FOR EXTERNAL USE ONLY. Flammaable. Keep away form excessive heat of open flame. CONTENTS UNDER
PRESSURE. DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURE ABOVE 120°F.
Warnings And Precautions
When using this product; Avoid contact with eyes or mucous membranes. Do not apply to wounds or damages skin.
Do not use with others sprays, ointments, creams, sprays of liniments. Do not apply to irritated skin or if excessive
irritation develops. Do not bandage. Wash hands after use with cold water. Do not use with heating pad or device.
Otc - Stop Use
Stop Use and Ask a Doctor if: Condition worsens. If symptoms persist for more than 7 days, of if symptons clean up and
reoccur.
Otc - Keep Out Of Reach Of Children
Keep out of reach of Children. If swallowed, het medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If Pregnant of Breastfeeding; Consult a doctor before use.
Dosage & Administration
Directions
Adults and Children 12 years of age and older. Spray on the affected areas not more than 4 times daily, massage not
necceeary. Children under 12 years of age, Consult Physicial
Inactive Ingredient
Inactive Ingredients:
Inactive Ingredients: Alcohol Denat., Arnica Montana Flower Extract. Calendula Officinalis Flower Extract, Camellia
Sinensis Leaf Extract, Chamomilla Recultita (Matricana) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Augustifola
Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water
Otc - Questions
Distributed by C.D.M.A. Inc.©
43157 W 9 Mile Rd
Novi, NI 48375
www.qualitychoice.com
Questions: 248-449-9300
Package Label.Principal Display Panel
85 grams NDC52313-1131-1
Maximum Strength
Icy Cool™
Pain Relieving Spray
Menthol 10.5 % | Topical Analgesic
Relief from Aches and Pains Associated with Strains, Sprains, Simple Bachaches, Bruses and Arthritus
Quatity Choice®
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