Label: COLD THERAPY PAIN RELIEF- menthol 10.5% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 59450-777-03 - Packager: Kroger
- 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 July 12, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Flammable: Do not use while smoking or near heat or flame.
When using this product • avoid contact with the eyes or mucous
membranes • do not apply to wounds or damaged skin • do not apply
to the irritated skin • do not bandage • wash hands after use with cool
water • do not use with heating pad or device
Stop use and ask a doctor if • condition worsens, or if symptoms
persist for more than 7 days, or clear up and reoccur. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients Alcohol Denat., Arnica Montana Flower
Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf
Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea
Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate,
Juniperus Communis Fruit Extract, Water - Questions or comments? 1-800-632-6900
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD THERAPY PAIN RELIEF
menthol 10.5% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59450-777 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 10.5 g in 100 g Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) Dimethyl Sulfone (UNII: 9H4PO4Z4FT) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) Isopropyl Myristate (UNII: 0RE8K4LNJS) JUNIPER BERRY (UNII: O84B5194RL) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59450-777-03 85 g in 1 CAN; Type 0: Not a Combination Product 04/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/03/2018 Labeler - Kroger (006999528) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(59450-777) , label(59450-777)
