Pain Relief Cream: Package Insert and Label Information

PAIN RELIEF CREAM- menthol cream
HEMPFUSION, 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.

Active ingredient

Menthol 1.75%

Purpose

Menthol 1.75%……..Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muslces and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

When using this product

• avoid contact with eyes
• do not bandage tightly
• do not apply to wounds or damaged skin

Stop use and ask doctor if

• condition worsens
• irritation occurs
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional 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 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Other information

• Store in a cool dry place away from light

Inactive ingredients

water (aqua), coco-caprylate, jojoba (simmondsia chinensis) esters, peppermint (mentha piperita) leaf oil, MSM (methylsulfonylmethane), cetearyl olivate, cetearyl alcohol, glycerin, organic hemp (cannabis sativa) aerial part extract, organic hemp

(cannabis sativa) seed oil, sorbitan olivate, organic aloe (aloe barbadensis) leaf juice, ethylhexylglycerin, glucose, cetearyl glucoside, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, dehydroxanthan gum, lactoperoxidase, glucose oxidase,
magnesium sulfate

Questions or comments?

Call 877-669-4367 Monday through Friday, 9am-5pm EST.

Principal Display Panel

Hemp Fusion

Pain

Relief

CREAM

Menthol 1.75%

Including hemp extarct with naturally occuring CBD (60mg/bottle) + Terpenes (55mg/bottle) from black pepper and clove & other natural skin moisturizers.

U.S. HEMP AUTHORITY H CERTIFIED

NON-GMO

ALL SKIN TYPES

50mL (1.69 fl oz)

PAIN RELIEF CREAM menthol 1.75% cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73672-987 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 17.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER PEPPERMINT OIL (PEPPERMINT) GLYCERIN SORBITAN OLIVATE ALOE CETEARYL GLUCOSIDE CLOVE OIL MAGNESIUM SULFATE, UNSPECIFIED FORM COCO-CAPRYLATE HYDROLYZED JOJOBA ESTERS (ACID FORM) DIMETHYL SULFONE CETEARYL OLIVATE CETOSTEARYL ALCOHOL HEMP ETHYLHEXYLGLYCERIN ANHYDROUS DEXTROSE BLACK PEPPER OIL MYELOPEROXIDASE GLUCOSE OXIDASE DEHYDROXANTHAN GUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73672-987-50 1 TUBE in 1 CARTON contains a TUBE 1 50 mL in 1 TUBE This package is contained within the CARTON (73672-987-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/10/2020

Labeler — HEMPFUSION, INC. (117152485)

Establishment
Name	Address	ID/FEI	Operations
Universal Packaging Systems, Inc. (DBA Paklab)		177711082	manufacture (73672-987)

Revised: 03/2021 HEMPFUSION, INC.