PAIN RELIEF BALM- menthol 4% 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.

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Pain Relief Balm

Active ingredient

Menthol 4%

Purpose

Menthol 4%...................Topical Analgesic

Uses

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

Warnings

For external use only

When using this product

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

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

organic shea (burtyrospermum parkii) butter, organic carnauba (copernicia cerifera) wax, peppermint leaf oil (mentha piperita), organic sunflower (helianthus annuus) seed oil, organic jojoba (simmondsia chinensis) seed oil, organic coconut (cocos nucifera) oil, cetearyl olivate, sorbitan olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, black pepper (piper nigrum) fruit oil (source of terpenes), clove (syzygium aromaticum) flower oil, magnesium sulfate, rosemary (rosmarinus officinalis) extract

Manufactured for HempFusion

3820 NW 14th Street Suite A & B

Topeka, KS 66618

877.NOW.HEMP (877.669.4367)

hempfusion.com

Principal Display Panel

Pain

Relief

BALM

HempFusion

Menthol 4%

Including hemp extract with naturally occurring CBD (50mg/jar) + Terpenes (45mg/jar) from black pepper and clove & other nautral skin moisturizers

NON-GMO

ALL SKIN TYPES

1.4 oz (40g)

BoxLabel

PAIN RELIEF BALM 
menthol 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-988
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
ROSEMARY (UNII: IJ67X351P9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HEMP (UNII: TD1MUT01Q7)  
BLACK PEPPER OIL (UNII: U17J84S19Z)  
SHEA BUTTER (UNII: K49155WL9Y)  
JOJOBA OIL (UNII: 724GKU717M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CLOVE OIL (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73672-988-401 in 1 CARTON02/10/2020
140 g in 1 CONTAINER; 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(73672-988)

Revised: 3/2021
Document Id: bdc68734-382e-0f6a-e053-2a95a90ae26f
Set id: 9edfe475-64f9-2a44-e053-2995a90a058b
Version: 3
Effective Time: 20210317
 
HEMPFUSION, INC.