PAIN RELIEF BALM- menthol 4% cream

Pain Relief Balm by

Drug Labeling and Warnings

Pain Relief Balm 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 ingredient

Menthol 4%

Purpose

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

Uses

For the temporary relief of minor aches and pains of muslces 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 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

• Store in a cool dry place away from light

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

QUESTIONS

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)

INGREDIENTS AND APPEARANCE

PAIN RELIEF BALM 
menthol 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73672-988
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEPPERMINT OIL (UNII: AV092KU4JH)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ROSEMARY (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73672-988-40	1 in 1 CARTON	02/10/2020
1		40 g in 1 CONTAINER; 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 - Metacan Inc Ste (034175227)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		078717086	manufacture(73672-988)