Active ingredients

Capsaicin 0.17%

Purpose

External Analgesic

Uses temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, muscle strains, sprains and bruises.

Warnings

For external use only

Do Not Use

on wounds or damaged skin
with tight bandages

When using this product

avoid contact with the eyes and mucous membranes

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
skin redness or excessive irritation of the skin develops

if pregnant or breast-feeding, ask a health professional before use.

keep out of reach of children, if swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 2 years of age and older: Apply a thin layer to the affected area in the morning and evening on dry clean skin
Recommended use for at least two weeks consistently
Children under 2 years of age: consult a physician

Other information

Store below 25°C (77°F)
This package has a tamper-evident seal. If the seal is broken, do not use

Inactive Ingredients Ascorbic Acid (Vitamin C), Cetyl alcohol, Distilled water, Glucosamine sulphate, Methylparaben, Methylsothiazolinone, Methylsulfonylmethane, Natural triglycerides (Omega-3), Peppermit extract, Polyethyleneglycol esters.

Questions?

Call 1 (888) 434-2235; 9am - 5pm EST

Or visit: www.GellertHealth.com

Principal Display Panel - Gellert Joint Care - 45g Carton

GELLERT JOINT CARE
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49834-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.17 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)	73.748 g in 100 g
Glucosamine Sulfate (UNII: 1FW7WLR731)	8 g in 100 g
Octanoic Acid (UNII: OBL58JN025)	8 g in 100 g
Glyceryl Monostearate (UNII: 230OU9XXE4)	3 g in 100 g
Butylene Glycol (UNII: 3XUS85K0RA)	1.8 g in 100 g
Cetyl Alcohol (UNII: 936JST6JCN)	1.5 g in 100 g
Dimethicone (UNII: 92RU3N3Y1O)	0.8 g in 100 g
Methylparaben (UNII: A2I8C7HI9T)	0.12 g in 100 g
Peppermint Oil (UNII: AV092KU4JH)	0.05 g in 100 g
Methylisothiazolinone (UNII: 229D0E1QFA)	0.05 g in 100 g
Curcumin (UNII: IT942ZTH98)	0.001 g in 100 g
FD&C Yellow No. 5 (UNII: I753WB2F1M)	0.006 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49834-001-01	48.19 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2009

Labeler - Gellert Health Solutions LLC (832894104)

Registrant - Gellert Health Solutions LLC (832894104)

Name	Address	ID/FEI	Business Operations
Establishment
Licht Far East (S) Pte. Ltd.		894670728	manufacture