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

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.

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Drug Facts

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

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

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

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 information
Store in a cool dry place with lid closed tightly

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.

image description

COLD THERAPY PAIN RELIEF ROLL-ON  MEIJER
menthol 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-788
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-788-0385 g in 1 TUBE; Type 0: Not a Combination Product07/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/11/2018
Labeler - Meijer (006959555)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(41250-788) , label(41250-788)

Revised: 7/2018
Document Id: af21fa15-71ed-4744-b84c-b678caa4d3fe
Set id: de712d51-d2f8-4a31-b0a6-e6c8f599946b
Version: 2
Effective Time: 20180711
 
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