MEIJER COLD AND HOT PAIN RELIEVING   ANALGESIC- lidocaine hydrochloride and menthol, unspecified form 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.

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Meijer® Cold & Hot Pain Relieving Cream
Topical Analgesic

Drug Facts

Active ingredientsPurpose
Lidocaine HCl 4%Topical analgesic
Menthol 1%Topical analgesic

Use

temporarily relieves minor pain

Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton.
  • rare cases of serious burns have been reported with products of this type
  • do not bandage or apply local heat (such as heating pads) to the area of use with a medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several days

Discontinue use and consult a doctor if

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

If pregnant or breast-feeding, 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) immediately.

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.

Questions or comments?

1-866-567-8600

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

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

meijer®

Compare to
Icy Hot® Active
Ingredients*

cold & hot
Pain Relieving Cream
Menthol 1% | Lidocaine 4%

Helps to Numb Away Pain | Non-Greasy

Maximum Strength External
Analgesic with 4% Lidocaine

NET WT 2.7 OZ (77g)

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
MEIJER COLD AND HOT PAIN RELIEVING   ANALGESIC
lidocaine hydrochloride and menthol, unspecified form cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-355
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Ceteth-20 Phosphate (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Isohexadecane (UNII: 918X1OUF1E)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Steareth-21 (UNII: 53J3F32P58)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-355-011 in 1 CARTON04/20/2020
177 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/20/2020
Labeler - Meijer Distribution, INC (006959555)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC.255106239MANUFACTURE(41250-355)

Revised: 1/2022
Document Id: f334ecbb-c950-4051-bdcf-2117e152abbc
Set id: 6d356563-9098-4994-8ad8-819a8033a9f4
Version: 2
Effective Time: 20220121
 
Meijer Distribution, INC