CAPZIX- capsaicin cream 
Toprail Chp Llc.

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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CAPZIX CREAM

Active Ingredient: Capsaicin 0.1%

Purpose: Topical Analgesic

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings: For external use only. Avoid contact with eyes.
Do not apply to wounds or damaged skin. Do not bandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask  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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions – Adults and children over 18
Apply to affected area not more than 3 to 4 times daily.
If product comes in contact with hands, wash with soap and water.
For children under 18 years of age ask a doctor.

Other Information: STORE TIGHTLY CLOSED, IN A COOL DRY PLACE

Inactive Ingredients: Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.

High Potency Pain Relief

For Arthritis, Sore Muscles, Joint and Back Pain Relief

NDC# 72847-316-20

Distributed by: TopRail Medical Products   Glencoe, IL   www.toprailmedical.com   Made in the USA

Packaging

label

CAPZIX 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72847-316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITOL (UNII: 506T60A25R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72847-316-201 in 1 CARTON07/19/2019
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 finalpart34807/19/2019
Labeler - Toprail Chp Llc. (080783804)

Revised: 12/2020
Document Id: e5064721-5529-4cd6-a53e-dbc2df496adf
Set id: a4555840-cf8f-45d8-90bb-3581102b58a7
Version: 2
Effective Time: 20201230
 
Toprail Chp Llc.