GELLERT JOINT CARE - capsaicin cream
Gellert Health Solutions 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.

----------

Active Ingredient

Capsaicin 0.17%

Purpose

External Analgesic

For External Use Only

Avoid contact with the eyes and mucous membranes.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Keep out of reach of children.

Stop use and ask a doctor if

Skin redness or excessive irritation of the skin develops.

Do Not Use:

On wounds or damaged skin.
With tight bandages

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. Continue for 4 weeks even if the pain subsides.
Children under 2 years of age: consult a physician.

Inactive ingredients:

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

Other Information

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

Questions?

Call: 1-888-434-2235

or visit www.gellerthealthsolutions.com

Label Image

GELLERT JOINT CARE
capsaicin cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (Capsaicin)	Capsaicin	0.17 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water	73.748 g in 100 g
Glucosamine Sulfate	8 g in 100 g
Octanoic Acid	8 g in 100 g
Glyceryl Monostearate	3 g in 100 g
Butylene Glycol	1.8 g in 100 g
Cetyl Alcohol	1.5 g in 100 g
Dimethicone	0.8 g in 100 g
Methylparaben	0.12 g in 100 g
Peppermint Oil	0.05 g in 100 g
Methylisothiazolinone	0.05 g in 100 g
Curcumin	0.001 g in 100 g
FD&C Yellow No. 5	0.006 g in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:49834-001-02	96.39 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2009	03/09/2012

Labeler - Gellert Health Solutions LLC (832894104)

Registrant - Gellert Health Solutions LLC (832894104)

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

Revised: 03/2012 Gellert Health Solutions LLC