LAV PREMIUM HEMP FOR NECK AND BACK PAIN ARTHRITIS RELIEF- menthol cream
LAV CBD 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.

----------

LAV PREMIUM HEMP EXTRACT CREAM for Neck and Back Pain, Arthritis Relief

Drug Facts

Active Ingredient:

Menthol 4.00%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

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 used. Leave it in hot water for at least 10 minutes.

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:

Aloe Barbadensis Leaf (Aloe Vera Gel), Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa Hemp Oil, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice extract), C13-14 Isoparaffin, Isopropyl Alcohol, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid.

Package Labeling:

Label

LAV PREMIUM HEMP FOR NECK AND BACK PAIN ARTHRITIS RELIEF
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73384-165
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURETH-7 (UNII: Z95S6G8201)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73384-165-02	60 mL in 1 JAR; Type 0: Not a Combination Product	10/01/2019	11/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2019	11/30/2021

Labeler - LAV CBD Inc (117190927)

Revised: 1/2022

Document Id: d58c9897-6fb8-d3f5-e053-2a95a90a4595

Set id: 826e07a3-deb7-430d-b1af-ab13eb443bf6

Version: 2

Effective Time: 20220114

LAV CBD Inc