CAPZIX by Toprail Chp Llc. CAPZIX- capsaicin cream

CAPZIX by

Drug Labeling and Warnings

CAPZIX by is a Otc medication manufactured, distributed, or labeled by Toprail Chp Llc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Capsaicin 0.1%

PURPOSE

Purpose: Topical Analgesic

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CAPZIX 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72847-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72847-316-20	1 in 1 CARTON	07/19/2019
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	07/19/2019

Labeler - Toprail Chp Llc. (080783804)