RELIEF BALM- camphor, eucalyptus oil, menthol, methyl salicylate cream 
Dr.Sankunni's Ayurvedic Research Foundation Private Limited

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.

----------

Relief Balm

Active Ingredients   Purpose

Camphor 11%                                           Topical Analgesic

Eucalyptus Oil 10%                                    Anti-Inflammatory

Menthol 8%                                               Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%     Topical Analgesic

Uses:  Temporarily relieves minor aches & pains related to

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a poison control center immediately.

ZEN

for aches & pains

all natural relief balm coconut oil

ideal for:

aches & pains related to

rheumatoid arthritis

joint pain

backaches

bursitis

sore muscles

arthritis

leg cramps

sprains and strains

Directions:

WARNINGS For external use only

When using this product

Stop use and ask a doctor if

Inactive Ingredients

coconut oil, paraffin wax, white petroleum jelly, light liquid paraffin, beeswax, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil

labellabellabel

RELIEF BALM 
camphor, eucalyptus oil, menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70146-000
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) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CLOVE OIL (UNII: 578389D6D0)  
NUTMEG OIL (UNII: Z1CLM48948)  
CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BORNEOL (UNII: M89NIB437X)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70146-000-0020 g in 1 JAR; Type 0: Not a Combination Product10/19/2015
2NDC:70146-000-015 g in 1 JAR; Type 0: Not a Combination Product01/18/2016
3NDC:70146-000-025 g in 1 JAR; Type 0: Not a Combination Product01/18/201601/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/15/2015
Labeler - Dr.Sankunni's Ayurvedic Research Foundation Private Limited (650517704)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Sankunni's Ayurvedic Research Foundation Private Limited650517704manufacture(70146-000)

Revised: 6/2021
Document Id: c3f30ec6-a8a5-2744-e053-2995a90a1002
Set id: 52d12c2e-2bb9-479d-bc3b-dc1f0aaf489f
Version: 8
Effective Time: 20210604
 
Dr.Sankunni's Ayurvedic Research Foundation Private Limited