PROHEMP SOOTHING MENTHOL RUB 4%- menthol cream 
NATURE'S FUSIONS, LLC

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.

----------

ProHEMP Pain Relief Soothing Menthol Rub 4%

temporarily relieves minor aches and pains of muscles and joints due to • arthritis • simple backache • strains • tendonitis • bursitis • sprains • bruises • cramps

Menthol 4% - External Analgesic

Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Adults and children 12 or older: apply to affected area as needed, no more than 4 times daily. Children under 12 years: ask a doctor.

aloe vera, beta caryophyllene, cellulose, hemp extract, hyaluronic acid, natural fragrances (essential oils, terpenes), organic fractionated coconut oil, potassium citrate, potassium sorbate, purified water, quillaja saponaria extract

Adults and children 12 or older: apply to affected area as needed, no more than 4 times daily. Children under 12 years: ask a doctor.

For external use only

When using this product

• use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or to damaged or very sensitive skin • do not bandage tightly or use with a heating pad • Stop use and ask a doctor if • excessive redness or irritation is present • condition worsens • pain persists for more than 7 days • symptoms 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.

2 oz tube display panel

4 oz jar display panel 4 oz tub display panel

PROHEMP SOOTHING MENTHOL RUB 4% 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73769-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.BETA.-CARYOPHYLLENE ALCOHOL (UNII: 9Y50O7OH2E)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
FRAGRANCE 13576 (UNII: 5EM498GW35)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
HEMP (UNII: TD1MUT01Q7)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73769-100-6060 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2022
2NDC:73769-100-04113 mL in 1 JAR; Type 0: Not a Combination Product01/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2022
Labeler - NATURE'S FUSIONS, LLC (051472644)
Establishment
NameAddressID/FEIBusiness Operations
NATURE'S FUSIONS, LLC051472644manufacture(73769-100)

Revised: 1/2022
Document Id: d6eb46b9-1df9-5990-e053-2995a90ad5af
Set id: d683440d-d818-5818-e053-2995a90a208d
Version: 2
Effective Time: 20220131
 
NATURE'S FUSIONS, LLC