COLD THERAPY PAIN RELIEF- menthol 10.5% spray

Cold Therapy Pain Relief by

Drug Labeling and Warnings

Cold Therapy Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kroger, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                            Purpose
Menthol 10.5%..............................................................Topical Analgesic

PURPOSE

INDICATIONS & USAGE

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

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

Keep out of reach of children. If accidentally ingested get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

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 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

INGREDIENTS AND APPEARANCE

COLD THERAPY PAIN RELIEF 
menthol 10.5% spray

Product 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)