PAINONIL- eugenol, camphor, eucalyptus ointment

PainONil by

Drug Labeling and Warnings

PainONil by is a Otc medication manufactured, distributed, or labeled by PhytoBiologic Pharmaceutics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PainONil Active Ingredients

Active Ingredient	Strength	Purpose
Camphor	8%	External analgesic
Eucalyptus oil	5%	External analgesic
Eugenol	2%	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:

• Sprains
• sports injuries
• falls
• back & neck injuries
• inflammation
• swelling
• excessive use of joints

Warnings

• For external use only.
• Avoid contact with eyes and mucous membranes.
• Use only as directed.
• Stop use and consult a doctor if: Skin rash or allergy occurs.
• If pregnant or breast-feeding, or symptoms persist, consult medical professional.
• Keep out of children's reach. If swallowed, get immediate medical help.

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.

When Using This Product

• Do not apply excessive external heat

Stop Use Section

Stop use of this product and consult a doctor If:

• Skin rash occurs

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

• Store in room temperature 40 0F to 86 0F (4 0C to 30 0C)
• Bioactive formula has a natural color that can stain cloths

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 ?

Principal Display Panel - 25 g Tube & Carton

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

Net Wt: 0.90 OZ (25g)

INGREDIENTS AND APPEARANCE

PAINONIL 
eugenol, camphor, eucalyptus ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73417-758
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	80 mg  in 1 g
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW)	EUGENOL	20 mg  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73417-758-52	1 in 1 CARTON	08/12/2021
1		25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/12/2021

Labeler - PhytoBiologic Pharmaceutics LLC (117103844)

Registrant - PhytoBiologic Pharmaceutics LLC (117103844)

Establishment
Name	Address	ID/FEI	Business Operations
PhytoBiologic Pharmaceutics LLC		117103844	manufacture(73417-758) , label(73417-758)