PAIN RELIEF GEL- menthol 1.5% gel

Pain Relief Gel by

Drug Labeling and Warnings

Pain Relief Gel by is a Otc medication manufactured, distributed, or labeled by HEMPFUSION, INC., Universal Packaging Systems, Inc. (DBA Paklab). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL 
menthol 1.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73672-989
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73672-989-50	1 in 1 CARTON	02/10/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

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	Business Operations
Universal Packaging Systems, Inc. (DBA Paklab)		177711082	manufacture(73672-989)