PAINONIL- eugenol, camphor, eucalyptus ointment 
PhytoBiologic Pharmaceutics 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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PainONil 25g Tube for Sustained and Rapid Pain Relief

PainONil Active Ingredients

Active Ingredient

Strength

Purpose

Camphor

8%

External analgesic

Eucalyptus oil

5%

External analgesic

Eugenol2%Analgesic & Anesthetic

Purpose

For rapid and sustained relief of pain.

Uses

For rapid and sustained relief of pain in joints, muscles, and tendons caused due to:

Warnings

Directions

Apply a generous amount of the ointment (~1g) on the affected area 3 times daily and massage gently. For faster results*, apply mild heat at the effected area with a heat lamp or heat pad after each application.

Do not use for children under 5 years of age.


* Individual results may vary.

PainONil DrugFact

When Using This Product

Stop Use Section

Stop use of this product and consult a doctor If:

If pregnant or breat feeding

If pregnant or breast-feeding, or symptoms persist, consult medical professional before use

Keep Out of Reach of Children

Keep out of children's reach. If swallowed, get immediate medical help.

Other Information

PainONil Inner Label

Inactive Ingredients

Inactive ingredients
Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.

Questions or Comments ?

PainONil Contact

Principal Display Panel - 25 g Tube & Carton

PainONil TM - 25 g Tube & Carton
NDC 73417-718-25

Net Wt: 0.90 OZ (25g)

PainONil Outer Label

PAINONIL 
eugenol, camphor, eucalyptus ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73417-758
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)80 mg  in 1 g
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL20 mg  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FENUGREEK SEED (UNII: 654825W09Z)  
MUSTARD OIL (UNII: TYY1MA9BSY)  
PETROLATUM (UNII: 4T6H12BN9U)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
RUBIA CORDIFOLIA ROOT (UNII: 4V873H15CG)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TURMERIC (UNII: 856YO1Z64F)  
ONION JUICE (UNII: 77539R6FGN)  
GINGER (UNII: C5529G5JPQ)  
ANISE OIL (UNII: 6Y89129C8H)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73417-758-521 in 1 CARTON08/12/2021
125 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/12/2021
Labeler - PhytoBiologic Pharmaceutics LLC (117103844)
Registrant - PhytoBiologic Pharmaceutics LLC (117103844)
Establishment
NameAddressID/FEIBusiness Operations
PhytoBiologic Pharmaceutics LLC117103844manufacture(73417-758) , label(73417-758)

Revised: 7/2021
Document Id: c7df0ca8-1f2f-556f-e053-2995a90a195e
Set id: c62451b0-771e-a774-e053-2995a90a37d8
Version: 5
Effective Time: 20210724
 
PhytoBiologic Pharmaceutics LLC