ZOSTRIX ORIGINAL STRENGTH- capsaicin cream 
Akorn Consumer Health

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.

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Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

Topical Analgesic

Keep Out of Reach of Children

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

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.

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

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.

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.

Package/Label Principal Display Panel

442_carton

NDC 61787-442-02

CAPSAICIN 0.033% 

TOPICAL ANALGESIC

ORIGINAL STRENGTH

ZOSTRIX

NATURAL PAIN RELIEF

BLOCKS YOUR BODY’S

PAIN MESSENGER

NET WT 2 OZ (57 g)

ZOSTRIX ORIGINAL STRENGTH 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-442-021 in 1 CARTON01/09/2006
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/09/2006
Labeler - Akorn Consumer Health (117696761)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208MANUFACTURE(61787-442)

Revised: 12/2020
Document Id: 3ee455f1-c9cb-48b5-94d2-90a532d250f3
Set id: 0eb78397-d6a1-4086-9d6c-02b45b3b9424
Version: 3
Effective Time: 20201217
 
Akorn Consumer Health