COLD THERAPY PAIN RELIEF ROLL-ON MEIJER- menthol 4% gel

Cold Therapy Pain Relief Roll-On by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                   Purpose
Menthol 4%..........................................................Topical Analgesic

PURPOSE

INDICATIONS & USAGE

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

WARNINGS

Warnings
For external use only.
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 or if excessive irritation develops do not
bandage 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 occur again within 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. If accidentally ingested get
medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions
Adults and children 12 years of age and older: Apply on to the
affected areas not more than 3-4 times daily.
Children under 12 years of age: Consult physician

OTHER SAFETY INFORMATION

Other information
Store in a cool dry place with lid closed tightly

INACTIVE INGREDIENT

Inactive ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock)
Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin
Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract,
Camphor, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Ilex
Paraguariensis (Mate) Leaf Extract, Isopropyl Alcohol, Isopropyl
Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica,
Tocopheryl Acetate, Triethanolamine, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD THERAPY PAIN RELIEF ROLL-ON  MEIJER
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-788
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
Glycerin (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
Isopropyl Alcohol (UNII: ND2M416302)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-788-03	85 g in 1 TUBE; Type 0: Not a Combination Product	07/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/11/2018

Labeler - Meijer (006959555)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(41250-788) , label(41250-788)