C.D.M.A ICY COOL- cold therapy muscle spray 
Sklar BOV Solutions Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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C.D.M.A. Icy Cool

Active Ingredient Purpos

Menthol 10.5% Topical Analgesic

Uses - Topical Analgesic

INDICATIONS AND USAGE

Temporary relief form minor aches and pains of sore muscles and joints associated with arthritis backache, strains and sprains

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.

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.

Stop Use and Ask a Doctor if: Condition worsens. If symptoms persist for more than 7 days, of if symptons clean up and

reoccur.

Keep out of reach of Children. If swallowed, het medical help or contact a Poison Control Center right away.

If Pregnant of Breastfeeding; Consult a doctor before use.

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 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

Distributed by C.D.M.A. Inc.©

43157 W 9 Mile Rd

Novi, NI 48375

www.qualitychoice.com

Questions: 248-449-9300

Icy Cool Label85 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®

C.D.M.A ICY COOL 
cold therapy muscle spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52313-1131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA (UNII: O80TY208ZW)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)  
CHAMOMILE (UNII: FGL3685T2X)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
WATER (UNII: 059QF0KO0R)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52313-1131-185 g in 1 CAN; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/23/2020
Labeler - Sklar BOV Solutions Inc (800463486)
Registrant - Sklar BOV Solutions, Inc (800463486)
Establishment
NameAddressID/FEIBusiness Operations
Sklar BOV Solutions, Inc800463486manufacture(52313-1131)

Revised: 1/2022
Document Id: d6e70a10-c94d-d82b-e053-2a95a90acfba
Set id: a85c0383-0a0d-0552-e053-2995a90a37ae
Version: 2
Effective Time: 20220131
 
Sklar BOV Solutions Inc