Label: COLD THERAPY PAIN RELIEF MEDICATED GNP- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 46122-657-21 - Packager: Amerisource Bergen
- 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 12, 2021
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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Wamings
For external use only.
Flammable: Do not use while smo~ng 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 atter use with cool water • do not use with heating pad or device
Stop use and ask a doctor if • condition worsens, or tt symptoms persist for more than 7 days, or clear up and reoccur again within a few days.
- Keep out of reach of children.
- Directions
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD THERAPY PAIN RELIEF MEDICATED GNP
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-657 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 WHOLE (UNII: VB06AV5US8) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) JUNIPER BERRY (UNII: O84B5194RL) WATER BUFFALO (UNII: 0A4PW6CRAI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-657-21 85 g in 1 CAN; Type 0: Not a Combination Product 01/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/12/2021 Labeler - Amerisource Bergen (007914906) Registrant - Inspec Solutions LLC (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC 081030372 manufacture(46122-657)
