Painonil Active Ingredients
Active Ingredient | Strength | Purpose |
Camphor | 8% | External analgesic |
Eucalyptus oil | 5% | External analgesic |
| Eugenol | 2% | Analgesic & Anesthetic |
Painonil
FDA Label NDC 73417-758
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Phytobiologic Pharmaceutics Llc for the product Painonil (NDC 73417-758). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding painonil active ingredients, purpose, uses, warnings, directions, when using this product, stop use section, if pregnant or breat feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Painonil Drugfact (Pon Durgfact)
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
Painonil Inner Label (Painonil Tubeinnerlabel)
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 (Pon Contact)
Recent Major Changes
- Active Ingredients (Camphor -- 8% External analgesic, Eucalyptus Oil -- 5% External analgesic, Eugenol -- 2% Analgesic & Anesthetic)
- 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.
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 Tubeouterlabel)
* Please review the disclaimer below.
