PAIN RELIEF GEL- menthol 1.5% 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.

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Pain Relief Gel

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

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

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.

HempFusion

Pain ReliefGel

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

bottle

PAIN RELIEF GEL 
menthol 1.5% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-989
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
HEMP (UNII: TD1MUT01Q7)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALOE (UNII: V5VD430YW9)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
CLOVE OIL (UNII: 578389D6D0)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
WATER (UNII: 059QF0KO0R)  
CAPSICUM (UNII: 00UK7646FG)  
GINGER (UNII: C5529G5JPQ)  
TURMERIC OIL (UNII: 6KGS8SP16U)  
MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BLACK PEPPER OIL (UNII: U17J84S19Z)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73672-989-501 in 1 CARTON02/10/2020
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/10/2020
Labeler - HEMPFUSION, INC. (117152485)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging Systems, Inc. (DBA Paklab)177711082manufacture(73672-989)

Revised: 3/2021
Document Id: bdc694d9-cc93-515d-e053-2a95a90aec0a
Set id: bb270f7b-e5b6-41a4-e053-2995a90a559f
Version: 3
Effective Time: 20210317
 
HEMPFUSION, INC.