GELLERT JOINT CARE  - capsaicin cream 
Gellert Health Solutions LLC

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Gellert Joint Care

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

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GELLERT JOINT CARE  capsaicin   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 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

Labeler - Gellert Health Solutions LLC (832894104)

Registrant - Gellert Health Solutions LLC (832894104)

Establishment
Name	Address	ID/FEI	Operations
Licht Far East (S) Pte. Ltd.		832894104	manufacture

Revised: 08/2009Gellert Health Solutions LLC