Pain Relief Balm

Drug Facts

Composition & Product

Active Ingredients

Menthol (40 mg)

Inactive Ingredients

Sunflower Oil Peppermint Magnesium Sulfate, Unspecified Form Rosemary Carnauba Wax Hemp Black Pepper Oil Shea Butter Jojoba Oil Coconut Oil Cetearyl Olivate Sorbitan Olivate Clove Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-02-10

Medication Information

Purpose

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

Description

Menthol 4%

Uses

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

simple backache
arthritis
strains
bruises
sprains

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product

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

Section 53413-1

Manufactured for HempFusion

3820 NW 14th Street Suite A & B

Topeka, KS 66618

877.NOW.HEMP (877.669.4367)

hempfusion.com

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only

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.

Active Ingredient

Menthol 4%

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

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)

Structured Label Content

Uses

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

simple backache
arthritis
strains
bruises
sprains

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

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

Section 53413-1 (53413-1)

Manufactured for HempFusion

3820 NW 14th Street Suite A & B

Topeka, KS 66618

877.NOW.HEMP (877.669.4367)

hempfusion.com

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

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

Warnings

For external use only

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.

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

Store in a cool dry place away from light

Inactive Ingredients (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

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)

Advanced Ingredient Data

[{"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SULFATE, UNSPECIFIED FORM", "unii": "DE08037SAB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSEMARY", "unii": "IJ67X351P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HEMP", "unii": "TD1MUT01Q7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BLACK PEPPER OIL", "unii": "U17J84S19Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARYL OLIVATE", "unii": "58B69Q84JO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN OLIVATE", "unii": "MDL271E3GR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains of muslces and joints associated with simple backache arthritis strains bruises sprains", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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", "50567-7": "When using this product avoid contact with eyes do not apply to wounds or damaged skin do not bandage tightly", "53413-1": "Manufactured for Hemp Fusion 3820 NW 14th Street Suite A & B Topeka, KS 66618 877.NOW.HEMP (877.669.4367) hemp fusion.com", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "Purpose": "Menthol 4%...................Topical Analgesic", "Warnings": "For external use only", "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.", "Active ingredient": "Menthol 4%", "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", "Principal Display Panel": "Pain Relief BALM Hemp Fusion 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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information