BAKERS BEST PAIN RELIEF WITH PURE HEMP SEED OIL- lidocaine hydrochloride, menthol cream 
BAKER'S BEST HEALTH PRODUCTS, 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.

----------

BAKER'S BEST Pain Relief Cream with Pure Hemp Seed Oil

Drug Facts

Active Ingredients

Lidocaine HCl (4.00%)

Menthol (1.00%)

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of pain, and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings:

For external use only

Use only as directed

Do not use

  • in large quantities, over raw skin or blistered areas.
  • Avoid contact with eyes. 
  • If symptoms worsen or persist for more than 7 days, then discontinue use and consult a doctor.
  • Do not bandage or apply local heat to area of use.

If pregnant or breast feeding,

  • ask a doctor before use,

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children over 12 years: Apply a thin layer to affected area not more than 3 to 4 times in 24 hours.

Children under 12 years: consult a doctor before use.

Additional Information:

  • Store at room temperature.

Other Ingredients:

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

Package Labeling:

Label

BAKERS BEST PAIN RELIEF WITH PURE HEMP SEED OIL 
lidocaine hydrochloride, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76102-389
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
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)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76102-389-0056.7 g in 1 JAR; Type 0: Not a Combination Product02/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/03/2023
Labeler - BAKER'S BEST HEALTH PRODUCTS, INC. (967388476)

Revised: 1/2023
Document Id: f2ffce06-aa31-d5d1-e053-2995a90a74f4
Set id: ae54c234-bfe4-4a74-b293-db7efda7884b
Version: 1
Effective Time: 20230124
 
BAKER'S BEST HEALTH PRODUCTS, INC.