Pain Relief Gel: Package Insert and Label Information

PAIN RELIEF GEL- menthol gel
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 Ingredients

Menthol 1.5%

Purpose

Menthol 1.5%……..Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles 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), glycerin, peppermint (mentha piperita) leaf oil, coco-caprylate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, organic aloe (aloe barbadensis) leaf juice, arnica (arnica montana) flower extract, pepper (capsicum annuum) fruit extract, ginger (zingiber officinale) root extract, organic turmeric (curcuma longa) root oil, organic rosemary (rosmarinus officinalis) leaf oil, black pepper (piper nigrum) fruit oil, clove (syzgium aromaticum) flower oil, jojoba (simmondsia chinensis) esters, lysolecithin, sclerotium gum, ethylhexylglycerin, glucose, pullulan, xanthan gum, glucose oxidase, lactoperoxidase, silica, magnesium sulfate, organic eucalyptus (eucalyptus globulus) leaf oil

Questions or comments?

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

Hemp Fusion

Pain Relief Gel

Menthol 1.5%

Including moisturizing Arnica , hemp extract with naturally occuring CBD (65mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers

U.S. HEMP AUTHORITY CERTIFIED

NON-GMO

ALL SKIN TYPES

50mL (1.69 fl oz)

carton
(click image for full-size original)
bottle
(click image for full-size original)
PAIN RELIEF GEL
menthol 1.5% gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73672-989
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CANNABIS SATIVA SEED OIL
ARNICA MONTANA FLOWER
HEMP
PEPPERMINT OIL
ALOE
ROSEMARY OIL
CLOVE OIL
HYDROLYZED JOJOBA ESTERS (ACID FORM)
WATER
CAPSICUM
GINGER
TURMERIC OIL
MYELOPEROXIDASE
SILICON DIOXIDE
BLACK PEPPER OIL
BETASIZOFIRAN
ETHYLHEXYLGLYCERIN
ANHYDROUS DEXTROSE
PULLULAN
XANTHAN GUM
GLUCOSE OXIDASE
EUCALYPTUS OIL
COCO-CAPRYLATE
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN
MAGNESIUM SULFATE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73672-989-50 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (73672-989-50)
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 (73672-989)

Revised: 03/2021 HEMPFUSION, INC.

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