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:

Label3 Label4

BAKERS BEST MAXIMUM STRENGTH PAIN RELIEF
lidocaine hydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76102-031
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
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76102-031-02	56.7 g in 1 JAR; Type 0: Not a Combination Product	07/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/08/2019

Labeler - Baker's Best Health Products, LLC (967388476)

Baker's Best Maximum Strength Pain Relief