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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Zen Hemp Balm

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

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

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

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

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

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 to avoid accidental ingestion.

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

Uses: Temporarily relieves minor aches & pains related to

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

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

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

label

ZEN HEMP BALM 
camphor, eucalyptus oil, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73048-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)11 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL10 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73048-001-0120 g in 1 JAR; Type 0: Not a Combination Product04/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/22/2019
Labeler - Zen Enterprises LLC (063099830)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Sankunni's Ayurvedic Research Foundation Private Limited650517704manufacture(73048-001)

Revised: 6/2021
Document Id: c4422161-474e-c082-e053-2995a90adffc
Set id: 85ba819e-830b-0c84-e053-2991aa0a5118
Version: 3
Effective Time: 20210608
 
Zen Enterprises LLC