MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING  TOPICAL ANALGESIC- menthol, unspecified form and methyl salicylate cream 
Meijer Distribution, 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.

----------

Meijer® Extra Strength Cold & Hot TherapyPain Relieving Cream
Topical Analgesic

Drug Facts

Active ingredientsPurpose
Menthol 10%Topical analgesic
Methyl Salicylate 30%Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only

Test on a small patch before applying generously.

Allergy alert

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

  • use only as directed. Read and follow all directions and warnings on this label
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in seven days

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children over 12 years:

Children 12 years or younger: ask a doctor

Other information

Keep tightly closed. Store at room temperature.

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, carbomer, ceteareth-20, cetearyl alcohol, oleth-3 phosphate, phenoxyethanol, polysorbate 60, sodium hydroxide, stearic acid, water.

Questions or comments?

1-866-567-8600

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

Compare to
Icy Hot®Active
Ingredients*

meijer®

EXTRA STRENGTH
cold & hot therapy

Menthol 10% (Topical Anangesic)
Methyl Salicylate 30% (Topical Anangesic)

Pain Relieving Cream

Body & Backache | Bruises | Arthritis | Sore Muscles

NET WT 1.25 OZ (35.4 g)

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton
MEIJER EXTRA STRENGTH COLD AND HOT THERAPYPAIN RELIEVING   TOPICAL ANALGESIC
menthol, unspecified form and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form100 mg  in 1 g
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-378-011 in 1 CARTON11/30/2020
135.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/30/2020
Labeler - Meijer Distribution, INC (006959555)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC.255106239MANUFACTURE(41250-378)

Revised: 1/2022
Document Id: b6c0988e-6f57-45c0-9832-f3278abd2050
Set id: 781f89c0-94ab-48de-9e0b-decb37bcde46
Version: 2
Effective Time: 20220121
 
Meijer Distribution, INC