Cold Therapy Pain Relief Medicated Spray [GNP]

Cold Therapy Pain Relief Medicated by

Drug Labeling and Warnings

Cold Therapy Pain Relief Medicated by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLD THERAPY PAIN RELIEF MEDICATED GNP- menthol spray 
Amerisource Bergen

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Cold Therapy Pain Relief Medicated Spray [GNP]

Active ingredient                                   Purpose

Menthol 10.5% ....................... . ........... Topical Analgesic

Uses

Temporary relief from minor aches and pains of muscles and joints associated with arthrttis, simple backache, strains and sprains

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.

If accidentally ingested get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult physician.

Inactive ingredients

Alcohol Denat.,Arnica Montana Flower Extract, Calendula Officinalis
Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita
Flower Extract, Dimethyl Sulfone, EchinaceaAngustifolia Extract,
llex Paraguariensis Leaf Extract, lsopropyl Myristate, Juniperus
Communis Fruit Extract, Water

Questions?

 888-793-8450

COLD THERAPY PAIN RELIEF MEDICATED  GNP
menthol spray

Product 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 Drug	M017	01/12/2021	12/09/2025

Labeler - Amerisource Bergen (007914906)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(46122-657)

Revised: 12/2025

Document Id: 4586884a-0e5d-cae8-e063-6394a90abaa8

34390-5

Set id: 1c1e6ca9-ef43-4e19-88a1-704963250426

Version: 4

Effective Time: 20251209