Zostrix Original Strength (capsaicin) Health, cream (.25 mg per 1 g)

Zostrix Original Strength (capsaicin) Health, cream (.25 mg per 1 g)

Company Details

Company Name:

Process Technologies & Packaging, LLC

Address:

ID/FEI:

809172885

Business Operations:

MANUFACTURE(61787-442)

Active Ingredient(s):

CAPSAICIN

Country:

country flag

Off On

PurposeCollapse

Topical Analgesic

UsesCollapse

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

DirectionsCollapse

•
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

WarningsCollapse

For external use only.

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

When Using This ProductCollapse

•
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 Collapse

•
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

Package/label Principal Display PanelCollapse

422_carton
ZOSTRIX ORIGINAL STRENGTH 
capsaicin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-442
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII: S07O44R1ZM) CAPSAICIN .25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description
1 NDC:61787-442-02 1 in 1 CARTON
1 56.6 g in 1 TUBE
Marketing Information (Status: active)
Marketing Category Application Number or Monograph Citation Marketing Start Date
OTC monograph not final part348 01/09/2006
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
Name ID/FEI Business Operations
Process Technologies & Packaging, LLC 809172885 MANUFACTURE(61787-442)

Collapse All Sections Collapse

Active IngredientCollapse

Capsaicin 0.025%

PurposeCollapse

Topical Analgesic

Keep Out Of Reach Of ChildrenCollapse

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

UsesCollapse

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

WarningsCollapse

For external use only.

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

When Using This ProductCollapse

•
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 Collapse

•
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

DirectionsCollapse

•
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 InformationCollapse

Store at 15°-30°C (59°-86°F)

Inactive IngredientsCollapse

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

Questions Or Comments?Collapse

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.

Package/label Principal Display PanelCollapse

422_carton
ZOSTRIX ORIGINAL STRENGTH 
capsaicin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-442
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII: S07O44R1ZM) CAPSAICIN .25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description
1 NDC:61787-442-02 1 in 1 CARTON
1 56.6 g in 1 TUBE
Marketing Information (Status: active)
Marketing Category Application Number or Monograph Citation Marketing Start Date
OTC monograph not final part348 01/09/2006
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
Name ID/FEI Business Operations
Process Technologies & Packaging, LLC 809172885 MANUFACTURE(61787-442)

Revised: 5/2014
Document Id: d88419df-456d-4f22-b86d-d8c6584422b1
Set id: 0eb78397-d6a1-4086-9d6c-02b45b3b9424
Version: 2
Effective Time: 20140508
 
Health Care Products