C.D.M.A ICY COOL- cold therapy muscle spray

C.D.M.A Icy Cool by

Drug Labeling and Warnings

C.D.M.A Icy Cool by is a Otc medication manufactured, distributed, or labeled by Sklar BOV Solutions Inc, Sklar BOV Solutions, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpos

Menthol 10.5% Topical Analgesic

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.

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.

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.

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

QUESTIONS

Distributed by C.D.M.A. Inc.©

43157 W 9 Mile Rd

Novi, NI 48375

www.qualitychoice.com

Questions: 248-449-9300

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®

INGREDIENTS AND APPEARANCE

C.D.M.A ICY COOL 
cold therapy muscle spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52313-1131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52313-1131-1	85 g in 1 CAN; Type 0: Not a Combination Product	06/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/23/2020

Labeler - Sklar BOV Solutions Inc (800463486)

Registrant - Sklar BOV Solutions, Inc (800463486)

Establishment
Name	Address	ID/FEI	Business Operations
Sklar BOV Solutions, Inc		800463486	manufacture(52313-1131)