Maximum Strength Pain Relief Cream

Maximum Strength Pain Relief Cream

Drug Labeling and Warnings

Drug Details

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MAXIMUM STRENGTH PAIN RELIEF- lidocaine hydrochloride, menthol cream 
Baker's Best Health Products, LLC

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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Maximum Strength Pain Relief Cream

Drug Facts

Active Ingredient:

Lidocaine HCl (4.00%), Menthol (1.00%)

Pain Reliever

Indications:

For the temporary relief of pain.

Warnings:

For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. 

If swallowed, consult physician.

Do not apply

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionize Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

Package Labeling:

Label3Label4

MAXIMUM STRENGTH PAIN RELIEF 
lidocaine hydrochloride, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76102-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURETH-7 (UNII: Z95S6G8201)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76102-031-0256.7 g in 1 JAR; Type 0: Not a Combination Product07/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/2019
Labeler - Baker's Best Health Products, LLC (967388476)

Revised: 7/2019
 
Baker's Best Health Products, LLC


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