ZEN SPORTS 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 Sports 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, get medical help or contact a poison control center immediately.

Uses

Temporary relives minor aches & pains related to

Directions:

CAUTIONS For external use only

When using this product

Stop use and ask a doctor if

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

label

label

ZEN SPORTS BALM 
camphor, eucalyptus oil, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73048-000
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)  
NUTMEG OIL (UNII: Z1CLM48948)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BORNEOL (UNII: M89NIB437X)  
PADANG CASSIA OIL (UNII: 0E15252LIW)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73048-000-01499 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 finalpart34810/15/2015
Labeler - Zen Enterprises LLC (063099830)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Sankunni's Ayurvedic Research Foundation Private Limited650517704manufacture(73048-000)

Revised: 6/2021
Document Id: c4422161-474d-c082-e053-2995a90adffc
Set id: 85ca4bbc-25b8-c688-e053-2991aa0a04e6
Version: 4
Effective Time: 20210608
 
Zen Enterprises LLC