PROHEMP SOOTHING MENTHOL RUB 4%- menthol cream

ProHEMP Soothing Menthol Rub 4% by

Drug Labeling and Warnings

ProHEMP Soothing Menthol Rub 4% by is a Otc medication manufactured, distributed, or labeled by NATURE'S FUSIONS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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

ACTIVE INGREDIENT

Menthol 4% - External Analgesic

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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.

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

4 oz jar display panel

INGREDIENTS AND APPEARANCE

PROHEMP SOOTHING MENTHOL RUB 4% 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73769-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73769-100-60	60 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2022
2	NDC: 73769-100-04	113 mL in 1 JAR; Type 0: Not a Combination Product	01/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/31/2022

Labeler - NATURE'S FUSIONS, LLC (051472644)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE'S FUSIONS, LLC		051472644	manufacture(73769-100)