Zestama Liquid
FDA Label NDC 72835-175

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by V2 Pharma Llc for the product Zestama (NDC 72835-175). 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 zestama, capsaicin 0.075%, external analgesic, uses, directionsadults and children 12 years of age and older:, fore external use only, do not use:, stop use and ask a doctor or pharmacist if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Zestama

Touch free pain relief

Capsaicin 0.075%

External Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis 
  • strains
  • sprains
  • bruises

Directionsadults And Children 12 Years Of Age And Older:

Apply Zestama using the touch free roll-on applicator to affected area liberally as needed for pain. Do not use more than 4 times per day. 

For children under 12 years of age, ask a doctor.

Fore External Use Only

Read all warnings and directions before use. 

Test first on small area of skin. 

When using this product you may experience a burning sensation and/or skin redness. The intensity of this reaction varies among individuals and may be severe. With regular use, this generally disappears after several days.

Do Not Use:

  • Near the face, eyes, or genetalia 
  • Immediately before or after bathing or swimming
  • On wounds or damaged skin
  • If you are allergic to capsicum or chili peppers
  • Do not bandage

Stop Use And Ask A Doctor Or Pharmacist If:

  • Condition worsens or does not improve after regular use
  • Severe burning persists or blistering occurs
  • Treated area skin begins to scale or peel as if burnt

If Swallowed, Get Medical Help Or Contact A Poison Control Center Immediately.

Instructions For Zestama Touch Free Pain Relief:

  • Lightly shake and invert bottle to allow product into applicator.
  • Remove cap to expose applicator. Try not to touch any surfaces or liquids.
  • Avoid contact with the eyes, lips, nose, genetalia and other mucous membranes.
  • Invert the bottle, then apply liberally to affected area 3 to 4 times daily.
  • Do not use hands to rub in.
  • Place cap back on and Wash hands thoroughly with soap and water.
  • Allow treated area to dry naturally for best results.
  • Do not swim or bathe for at least 1 hour.
  • Do not tightly wrap or bandage the treated area
  • Do not apply heat to the treated area immediately before or after use.
  • Moisture and sweat can further “activate” the treated area and warm up more

* Please review the disclaimer below.