Label: ZOSTRIX HP- capsaicin cream
- NDC Code(s): 61787-443-02
- Packager: Akorn Consumer Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 11, 2020
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- Active ingredient
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 diminishes.
• avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contract 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.
•difficulty breathing or swallowing occurs.
•severe burning persists.
•for persons under 18 years of age, ask a doctor before using.
•apply a thin film of cream to the affected area 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
- Inactive Ingredients
- Questions or Comments?
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61787-443 Route of Administration TOPICAL 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 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) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61787-443-02 1 in 1 CARTON 01/09/2006 1 56.6 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/09/2006 Labeler - Akorn Consumer Health (117696761) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 MANUFACTURE(61787-443)