Label: GELLERT JOINT CARE- capsaicin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49834-001-01 - Packager: Gellert Health Solutions LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 1, 2012
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INGREDIENTS AND APPEARANCE
GELLERT JOINT CARE
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49834-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.17 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49834-001-01 48.19 g in 1 TUBE 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 Business Operations Licht Far East (S) Pte. Ltd. 894670728 manufacture