ZEN HEMP BALM- camphor, eucalyptus oil, menthol, methyl salicylate cream

Zen Hemp Balm by

Drug Labeling and Warnings

Zen Hemp Balm by is a Otc medication manufactured, distributed, or labeled by Zen Enterprises LLC, Dr.Sankunni's Ayurvedic Research Foundation Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients....................................Purpose

Camphor 11%............................................Topical Analgesic

Eucalyptus Oil 10%....................................Anti-Inflammatory

Menthol 8%................................................Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%....Topical Analgesic

PURPOSE

Active Ingredients......................................Purpose

Camphor 11%............................................Topical Analgesic

Eucalyptus Oil 10%....................................Anti-Inflammatory

Menthol 8%................................................Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%....Topical Analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion.

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

INDICATIONS & USAGE

Uses: Temporarily relieves minor aches & pains related to

• headaches
• backaches
• joint and muscle pain
• cramps and spasms
• sprains and other sports related injuries

DOSAGE & ADMINISTRATION

Directions:

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

INACTIVE INGREDIENT

Inactive Ingredients

Narayani Oil, Clove Oil, Nutmeg Oil, Cassia Oil, Paraffin Wax, Cinnamon Oil, Peppermint Oil, White Petroleum Jelly, Borneol, Light Liquid Paraffin, Citronella Oil, Beeswax

WARNINGS

CAUTIONS

For external use only

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZEN HEMP BALM 
camphor, eucalyptus oil, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73048-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	11 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	10 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
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
CLOVE OIL (UNII: 578389D6D0)
NUTMEG OIL (UNII: Z1CLM48948)
PEPPERMINT OIL (UNII: AV092KU4JH)
BORNEOL (UNII: M89NIB437X)
CITRONELLA OIL (UNII: QYO8Q067D0)
CINNAMON OIL (UNII: E5GY4I6YCZ)
HEMP (UNII: TD1MUT01Q7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73048-001-01	20 g in 1 JAR; Type 0: Not a Combination Product	04/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/22/2019

Labeler - Zen Enterprises LLC (063099830)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Sankunni's Ayurvedic Research Foundation Private Limited		650517704	manufacture(73048-001)