Label: KANDESN- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62191-085-08 - Packager: Sunrider Manufacturing L.P.
- 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 April 22, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Water (Deionized), Salix Alba (Willow) Bark Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Camellia Sinensis Leaf Extract, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Laurus Nobilis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-40 Hydrogenated Castor Oil, Oleth-20, Fragrance
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- Principal Display Panel – 60 mL Bottle Label
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INGREDIENTS AND APPEARANCE
KANDESN
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62191-085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Salix Alba Bark (UNII: 205MXS71H7) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) Green Tea leaf (UNII: W2ZU1RY8B0) Menthol, Unspecified Form (UNII: L7T10EIP3A) Tea Tree Oil (UNII: VIF565UC2G) Bay Leaf (UNII: WS0Y3M85RF) Rosemary (UNII: IJ67X351P9) Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F) Oleth-20 (UNII: YTH167I2AG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62191-085-08 60 mL in 1 TUBE; Type 0: Not a Combination Product 04/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/22/2020 Labeler - Sunrider Manufacturing L.P. (786951475) Establishment Name Address ID/FEI Business Operations Sunrider Manufacturing L.P. 786951475 MANUFACTURE(62191-085)