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

Description

Capsaicin 0.025%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.025%

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

For external use only.

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

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
Active Ingredient

Capsaicin 0.025%

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.

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

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

Warnings

For external use only.

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

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
Active Ingredient (Active ingredient)

Capsaicin 0.025%

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.

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

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