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:

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

consult a doctor before use. Children under 12 years:

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76102-389
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76102-389-00	56.7 g in 1 JAR; Type 0: Not a Combination Product	02/03/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	02/03/2023

Labeler - BAKER'S BEST HEALTH PRODUCTS, INC. (967388476)

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