MEIJER COLD THERAPY PAIN RELIEF 360- cold therapy muscle spray

Meijer Cold Therapy Pain Relief 360 by

Drug Labeling and Warnings

Meijer Cold Therapy Pain Relief 360 by is a Otc medication manufactured, distributed, or labeled by Sklar BOV Solutions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Menthol 10.5% Cooling Pain Relief

PURPOSE

Use

Temporary relief of minor aches and pains of sore muscles and joints associated with arthritis, backaches, strains and springs.

WARNINGS

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame. Contents umder pressure. Do not store at temperatures above 120ºF.

INDICATIONS & USAGE

When using the product avoid contact with the eyes or mucous membranes.,do not apply to wounds or damaged skin, do

not apply to the irritated skin or if excessive irritation develops, do not bandage, do not use with heating pad of device.

Stop and ask a doctor if, condition worsens or if symptoms persist for more than 7 days or clear up and occur again with a few

days

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children. Iff accidentally ingested get medical help of contacat a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions , Adults and Children 12 yearsof age and older.

Spray on the affected areas not more that 4 times daily., massage not necessary.

Children under 12 years of age. Consult a doctor

WARNINGS AND PRECAUTIONS

Other informaton

Store in a cool dry place with lid closed tightly

INACTIVE INGREDIENT

Inactive Ingredients

Alcohol denat. arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, chamomillx recuitita (matricaria) flower extract, dimethyl sulfone (MSM), ecinacea angustifolia extract, ilex paraguariensis leaf extract, isopropyl myristate, juniperus communis fruit extract, water

QUESTIONS

Questions 1-800-255-3924

PRINCIPAL DISPLAY PANEL

85 grams NDC: 52313-1112-1 Cold Therapy pain relief 360º

Topical Analgesis

Soothing Menthol 10.5%

Paraben Free

For Arthritus, Sore Muscles, Back Pain and Joints.

Vanishing Scent

Spray at any angle.

INGREDIENTS AND APPEARANCE

MEIJER COLD THERAPY PAIN RELIEF 360 
cold therapy muscle spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52313-1112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
WATER (UNII: 059QF0KO0R)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
ARNICA MONTANA (UNII: O80TY208ZW)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)
ALCOHOL (UNII: 3K9958V90M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52313-1112-1	85 g in 1 CAN; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/04/2020

Labeler - Sklar BOV Solutions Inc (800463486)

Registrant - Sklar BOV Solutions Inc (800463386)

Establishment
Name	Address	ID/FEI	Business Operations
Sklar BOV Solutions Inc		800463486	manufacture(52313-1112)