drug facts

drug facts
SPL v3
SPL
SPL Set ID 0eb78397-d6a1-4086-9d6c-02b45b3b9424
Route
topical
Published
Effective Date 2020-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (.25 mg)
Inactive Ingredients
benzyl alcohol cetyl alcohol glyceryl monostearate isopropyl myristate peg-100 stearate water sorbitol petrolatum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2006-01-09

Purpose

Topical Analgesic

Description

Capsaicin 0.025%


Medication Information

Warnings

For external use only.

Do not apply to wounds or to damaged or irritated skin.

Uses
  • for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains
Purpose

Topical Analgesic

Directions
  • for persons under 18 years of age, ask a doctor before using
  • apply a thin film of cream and gently rub in until fully absorbed
  • for optimum relief, apply 3 to 4 times daily
  • best results typically occur after 2 to 4 weeks of continuous use
  • unless treating hands, wash hands thoroughly with soap and water immediately after use
  • see package insert for more information
Other Information

Store at 15°-30°C (59°-86°F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.

Description

Capsaicin 0.025%

Active Ingredient

Capsaicin 0.025%

Questions Or Comments?

Call: 1-866-263-9003, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

When Using This Product
  • you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days.
  • avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water.
  • do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise
  • do not apply heat to the treated areas immediately before or after use
  • do not tightly wrap or bandage the treated area
  • avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.
Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
  • blistering occurs
  • difficulty breathing or swallowing occurs
  • severe burning persists
Keep Out of Reach of Children

If swallowed, get medical help or contact a PoisonControlCenter immediately.

Package/label Principal Display Panel

NDC 61787-442-02

CAPSAICIN 0.033% 

TOPICAL ANALGESIC

ORIGINAL STRENGTH

ZOSTRIX

NATURAL PAIN RELIEF

BLOCKS YOUR BODY’S

PAIN MESSENGER

  • ODOR FREE CREAM
  • WARMTH FROM CHILI PEPPERS

NET WT 2 OZ (57 g)


Structured Label Content

Warnings

For external use only.

Do not apply to wounds or to damaged or irritated skin.

Uses
  • for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains
Purpose

Topical Analgesic

Directions
  • for persons under 18 years of age, ask a doctor before using
  • apply a thin film of cream and gently rub in until fully absorbed
  • for optimum relief, apply 3 to 4 times daily
  • best results typically occur after 2 to 4 weeks of continuous use
  • unless treating hands, wash hands thoroughly with soap and water immediately after use
  • see package insert for more information
Other Information (Other information)

Store at 15°-30°C (59°-86°F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.

Active Ingredient (Active ingredient)

Capsaicin 0.025%

Questions Or Comments? (Questions or Comments?)

Call: 1-866-263-9003, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

When Using This Product (When using this product)
  • you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days.
  • avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water.
  • do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise
  • do not apply heat to the treated areas immediately before or after use
  • do not tightly wrap or bandage the treated area
  • avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
  • blistering occurs
  • difficulty breathing or swallowing occurs
  • severe burning persists
Keep Out of Reach of Children

If swallowed, get medical help or contact a PoisonControlCenter immediately.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 61787-442-02

CAPSAICIN 0.033% 

TOPICAL ANALGESIC

ORIGINAL STRENGTH

ZOSTRIX

NATURAL PAIN RELIEF

BLOCKS YOUR BODY’S

PAIN MESSENGER

  • ODOR FREE CREAM
  • WARMTH FROM CHILI PEPPERS

NET WT 2 OZ (57 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)