ZEN HEMP BALM- camphor, eucalyptus oil,menthol,wintergreen oil ointment

ZEN HEMP Balm by

Drug Labeling and Warnings

ZEN HEMP Balm by is a Otc medication manufactured, distributed, or labeled by Zen Enterprises LLC, CLARION COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Camphor 11%

Eucalyptus Oil 10%

Menthol 8%

Wintergreen Oil (Methyl salicylate) 10%

Purpose

Topical Analgesic

Anti-Inflammatory

Topical Analgesic

Topical Analgesic

Uses

Temporarily relieves minor aches & pains releated to arthritis, headaches, backaches, joints and muscle pain, cramps and spasms, sprains and other injuries

Cautions

For external use only

When using this product

When using this product discontinue use if excessive irritation of the skin develops. Avoid contact with eyes and mucous membranes. Do not bandage. Do not use with a heating pad.

Stop use and ask a doctor if

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

• symptoms cear up and occur again within a few days or
• excessive skin irritation occurs.

Keep out of reach of children to avoid accidental ingestion.

If swallowed, seek medical attention or consult a physician immediately.

Other Information

Store in a cool, dry place between 20º to 25 ºC (68º-77ºF)

Directions

Use only as directed. Apply generously to affected area 3 to 4 times daily. Children under 12, consult a doctor before use.

Inactive ingredients

Hemp Oil

Clove Oil

Nutmeg Oil

Cassia Oil

Paraffin Wax

Cinnamon Oil

Pwppermint Oil

White Petroleum Jelly

Borneol Oil Light Liquid Paraffin

Citronella Oil

Beeswax

label

INGREDIENTS AND APPEARANCE

ZEN HEMP BALM 
camphor, eucalyptus oil,menthol,wintergreen oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73048-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	10 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	11 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CINNAMON OIL (UNII: E5GY4I6YCZ)
NUTMEG OIL (UNII: Z1CLM48948)
PARAFFIN (UNII: I9O0E3H2ZE)
BORNEOL (UNII: M89NIB437X)
CITRONELLA OIL (UNII: QYO8Q067D0)
PEPPERMINT OIL (UNII: AV092KU4JH)
CLOVE OIL (UNII: 578389D6D0)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73048-005-01	20 g in 1 JAR; Type 0: Not a Combination Product	08/13/2024
2	NDC: 73048-005-02	5 g in 1 JAR; Type 0: Not a Combination Product	08/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/13/2024

Labeler - Zen Enterprises LLC (063099830)

Establishment
Name	Address	ID/FEI	Business Operations
CLARION COSMETICS		862603166	manufacture(73048-005)