Meijer Cold Therapy Roll-On

Meijer Cold Therapy Roll-On

Drug Labeling and Warnings

Drug Details

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MEIJER COLD THERAPY ROLL ON- menthol gel 
Meijer Inc.

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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Meijer Cold Therapy Roll-On

Drug Facts

Active Ingredients

Menthol 4%

Purpose

Cooling Pain Relief

Uses

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

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

Sensitive skin

When using this product:

Avoid contact with the eyes or mucous membranes  Do not apply to wounds or damaged skin  Do not use with other ointments, creams, sprays, or liniments  Do not apply to irritated skin or if excessive irritattion develops  Do not bandage   Wash hands after use with cool water

Do not use 

with heating pad or device  Store in cool dry place.

Stop use and ask a doctor if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

If pregnant or breast-feeding:

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 2 years of age and older: rub a thin film over affected areas not more than four times daily; massage not necessary.
  • Children under 2 years of age: Consult physician

Inactive Ingredients

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

Package Labeling:

Label2

MEIJER COLD THERAPY ROLL ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41250-874
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41250-874-2574 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/201810/22/2018
2NDC: 41250-874-2174 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/22/2018
Labeler - Meijer Inc. (006959555)

Revised: 11/2019
 
Meijer Inc.


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