Zestama

Zestama
SPL v5
SPL
SPL Set ID c9b46759-b8df-4ff4-815e-8e032c2635c0
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.075 g)
Inactive Ingredients
Water Dimethicone Alcohol Dimethyl Sulfoxide Lavender Oil Decyl Glucoside Ginger Bambusa Vulgaris Top Pea Glucosamine Hcl Arnica Montana Flower Propylene Glycol Phenoxyethanol Ethylhexylglycerin Hydroxyethyl Cellulose (5500 Mpa.s At 2%) Allantoin Echinacea Purpurea Root Aloe Barbadensis Leaf Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Touch free pain relief


Medication Information

Description

Touch free pain relief

Uses

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

  • simple backache
  • arthritis 
  • strains
  • sprains
  • bruises
Section 42229-5

Manufactured for:

V2 Pharma, LLC

103 W Main Street

Hudson, MI 49247

Section 44425-7

Store tightly closed in a cool dry place. 

Section 51727-6

Water

Dimethicone

Alcohol

Dimethyl Sulfoxide

Lavender Oil

Decyl Glucoside

Ginger Extract

Bamboo Extract

Pea Extract

Glucosamine HCI

Arnica Extract

Propylene Glycol

Phenoxyethanol

Ethylhexylglycerin

Hydroxyethyl Cellulose

Allantoin

Echinacea Extract

Aloe Barbadensis Leaf Extract

Disodium EDTA

Section 51945-4

Zestama

Touch free pain relief

Directions

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.

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
Capsaicin 0.075%

External Analgesic

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.

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


Structured Label Content

Uses

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

  • simple backache
  • arthritis 
  • strains
  • sprains
  • bruises
Section 42229-5 (42229-5)

Manufactured for:

V2 Pharma, LLC

103 W Main Street

Hudson, MI 49247

Section 44425-7 (44425-7)

Store tightly closed in a cool dry place. 

Section 51727-6 (51727-6)

Water

Dimethicone

Alcohol

Dimethyl Sulfoxide

Lavender Oil

Decyl Glucoside

Ginger Extract

Bamboo Extract

Pea Extract

Glucosamine HCI

Arnica Extract

Propylene Glycol

Phenoxyethanol

Ethylhexylglycerin

Hydroxyethyl Cellulose

Allantoin

Echinacea Extract

Aloe Barbadensis Leaf Extract

Disodium EDTA

Section 51945-4 (51945-4)

Zestama

Touch free pain relief

Directions

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.

Do Not Use: (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
Capsaicin 0.075%

External Analgesic (External analgesic)

Fore External Use Only (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.

Stop Use and Ask A Doctor Or Pharmacist If: (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
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
If Swallowed, Get Medical Help Or Contact A Poison Control Center Immediately. (If swallowed, get medical help or contact a Poison Control Center immediately.)


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