Label: C.D.M.A ICY COOL- cold therapy muscle spray
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Contains inactivated NDC Code(s)
NDC Code(s): 52313-1131-1 - Packager: Sklar BOV Solutions Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 31, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
C.D.M.A ICY COOL
cold therapy muscle sprayProduct 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)