Label: ZOSTRIX FOOT PAIN RELIEF- capsaicin cream
- NDC Code(s): 61787-188-02
- Packager: Health Care Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
For the temporary relief of minor aches and pains of the muscle joints associated with
For external use only.
Do not apply to wounds or to damaged or irritated skin.
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
- blistering occurs
- difficulty breathing or swallowing occurs
- severe burning persists
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
- for persons under 18 years of age, ask a doctor before using
- to avoid getting cream on hands use applicator pad to apply a thin film of cream to the affected area and gently rub in until fully absorbed. Discard applicator pad after use.
- 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).Close
- Inactive ingredients
Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, Isopropyl Myristate, PEG-100 Stearate, Purified Water, Sorbitol Solution & White Petrolatum.Close
- Questions or Comments?
Call: 1-800-899-3116, Mon. - Thurs. 9:00 am - 5:00 pm EST, Fri. 9:00 am - 2:30 pm EST. Serious side effects associated with the use of this product may be reported to this number.
Rev. 188:01 3/11Close
- Package/Label Principal Display Panel
FOOT PAIN RELIEF CREAM
For Relief of Diabetic Foot Pain
- Clinically tested pain relief without a prescription
- Provides powerful penetrating relief
Net Wt. 2 oz. (56.6 g)
INCLUDES APPLICATOR PADS to keep hands medication free
TOPICAL ANALGESIC CREAMClose
- INGREDIENTS AND APPEARANCE
ZOSTRIX FOOT PAIN RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-188 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.75 mg in 1 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CETYL ALCOHOL (UNII: 936JST6JCN) PETROLATUM (UNII: 4T6H12BN9U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61787-188-02 1 in 1 CARTON 1 56.6 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2009 03/31/2016 Labeler - Health Care Products (101196749) Registrant - Hi-Tech Pharmacal Co., Inc. (101196749) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging, LLC 809172885 MANUFACTURE(61787-188)